Abbvie Contract MFG

Developing a new drug is a multifaceted venture requiring many decisions and evaluations before a commercial launch. Smaller pharmaceutical companies and biotech are increasingly deciding to outsource all or most of their drug production efforts all through the production stage.

Due to the high cost of facility build-out, staffing, validation, and support required to develop one product and the low rate of success of drug commercialization, the investment community does not care for the erection of production facilities to manufacture and fill a specialty medicine until profitable acceptance is impending.

AbbVie Contract Manufacturing is a leading manufacturer of Active Pharmaceutical Ingredients. We offer the best custom active pharmaceutical ingredient services based on over seventy years of manufacturing success.

Tips to Finding the Best CMO

Here are five things to look out for when hiring the best CMO:

1. Ensure compliance and quality standards For your reputation and safety, the Contract Manufacturing Organization you work with must have an excellent track record. Make sure they stand well with governing agencies such as the Food and Drug Administration.

2. Ensure there is room for growth Like choosing a Contract Manufacturing Organization with well-integrated depth and services, the Contract Manufacturing Organization you pick should have room for growth, too. The best Contract Manufacturing Organization is one that can grow with the success of your product. Intrinsically, this Contract Manufacturing Organization must have the right flexibility, staffing, and equipment to run your manufacturing cycle as it expands.

3. Be sure of their resources. Your Contract Manufacturing Organization should have the financial stability to support the lifecycle of your pharmaceutical product and a professional supply chain to protect you from doubts. Assess their equipment and facilities, and validate their capability availability against your commercial timelines and development.

Your pharmaceutical product must be of importance for your Contract Manufacturing Organization.

4. Confidentiality The subject of discretion can be crucial with regards to formulation production. A discreet agreement is a must, and it must function to benefit both parties. Assess how the potential Contract Manufacturing Organization ensures confidentiality.

The Contract Manufacturing Organization should have a system that prevents the use of client initials or names, locks information in a secure area, and sends the customer separate passwords for electronic access to documents.

Here are various aspects to consider when determining the best Contract Manufacturing Organization for your pharmaceutical product. The best way to create an effective partnership is to evaluate your needs and the Contract Manufacturing Organizations' previous expertise, reputation, capabilities, and abilities.

5. Look out for signs of a strong relationship From the start, there must be signs of a solid relationship between your brand and the Contract Manufacturing Organization. When speaking about a possible relationship, pay attention to how rapidly the Contract Manufacturing Organization in question responds to your communications. What is communicating with them like? Do they reach out to you? Consistent, open, and clear communication is key to an effective relationship.

The production of a new drug is a challenging responsibility and needs many decisions and evaluations before a commercial launch. Some small pharmaceutical companies and biotech are choosing to outsource all or most of their drug production efforts throughout the manufacturing phase with a Contract Manufacturing Organization.

Picking the best Contract Manufacturer is vital in pharmaceutical manufacturing to ensure the success of product and overall success in the performance of your company. Choosing the very best is a crucial decision that puts your brand's reputation, supply chain, and patient safety in the hands of a partner. For the best beneficial relationship and peace of mind, we have highlighted essential points to consider when choosing the best Contract Manufacturing Organization for your pharmaceutical product.

AbbVie Contract Manufacturing is a leading producer of custom active pharmaceutical ingredient.

Four Factors to Consider when Choosing the Best CMO:

Here are crucial factors to look out for:

1. Know Your Needs The first step to picking the best Contract Manufacturing Organization is to know exactly what you need. There are various Contract Manufacturing Organization relationships you can have based on your wants and needs. For example, a tactical contractor is excellent to fill gaps in in-house productions or for handling a single project.

Working with the best provider lets you establish a continuing relationship with a Contract Manufacturing Organization partner without giving up control over policymaking. On the other hand, a tactical partnership with a CMO is a long-term relationship between you and the Contract Manufacturing Organization to attain defined business objectives by exploiting the effectiveness of the resources of each participant.

Most pharmaceutical companies are searching for a Contract Manufacturing Organization to support their projects from the production phase, via clinical trials, and on to commercial API production and manufacturing, as well as drug product manufacturing, production, and packaging. For these businesses, a strategic partnership is the best option.

2. Create a List You want to create a list of potential Contract Manufacturing Organizations you are interested in working with, and evaluate every Contract Manufacturing Organization on the same requirements and characteristics to eventually single out the best partner. Finding Contract Manufacturing Organizations is as simple as asking industry colleagues for references or searching for local Contract Manufacturing Organizations on Google.

3. Consider their Proficiency With regards to proficiency of potential Contract Manufacturing Organizations is an essential step in the process. You will need to determine if your Contract Manufacturing Organization has the expertise and capability required to produce your product.

To carry this out, you want to consider their experience and expertise. You will want to be the trial run for your Contract Manufacturing Organization, so ask about their previous experience. Read reviews and research or consider employing a consultant to help you evaluate Contract Manufacturing Organizations. It is also essential to ask your potential Contract Manufacturing Organization to share the kind of main performance indicators they have in place and about their success in meeting the expectations of clients.

4. Depth is Key Contract Manufacturing Organizations offer well-integrated services. It is crucial to select Contract Manufacturing organizations with excellent services that scale from method and formulation development to commercial production and packaging, across a wide range of products, from APIs and products to fermentation, biologics, and packaging.

Almost fifty percent of high potency medicines are in injectable form. Semi-solid drugs come next. Due to increasing and high regulatory compliance, many companies with a few drugs in their manufacturing pipeline are searching for capable contract manufacturing organizations to fix these challenges. 

This blog centers on challenges that are being faced by the market with regards to the regional distribution of providers, supply, and how the increasing demand for highly potent drugs is affecting the market in terms of mergers and acquisitions, investing/upgrading in new capital, new facilities, capacity expansion, etc. Continue reading to learn more.

The Challenge 

High potent drug contract manufacturing is one of the major revenue-generating segments in the pharmaceutical industry. There is a high demand for high-potency drugs such as IV fluids and ADCs. On the other hand, buyers are searching for high-capacity suppliers with lyophilization proficiency in the form of injectable dosage, can meet their active pharmaceutical ingredients OEL limits, and have experience handling high-potency drugs.

The challenge is on the side of supply. There are not enough number of contract manufacturing organizations that meet the exact needs of buyers. Producing high potent drugs requires appropriate containment facility, contemporary technology, and technical expertise.

This translates into pricey capital and results in high costs of operation, causing the manufacturing process expensive. This is why fewer contract manufacturing organizations are available to meet pharma KPIs.

Trends 

In recent years, contract manufacturing organizations of highly potent medicines have invested in high potency drug production proficiencies. So also, high potent API manufacturers have increased their ability to meet the demand.

Presently there is no congestion in the market, yet investment is required from suppliers to meet the expected rising demand of big pharma companies. The general high potency active pharmaceutical ingredient drugs market is expected to experience solid growth because of the patent expirations.

There is also an increasing trend of pharmaceutical companies engaging with a partner who can provide high potency active pharmaceutical ingredient manufacturing and development services. This will help to limit the overall drug development cost and time.

Does the Market Have Sufficient Supply?

The high potency industry is expanding at a very fast rate. Lately, there has been a rising request for injectable highly potent medicines. This demand is greater than the ability of the contract manufacturing organizations. This need is chiefly for lyophilized products. A major constraint in the market is the need for specific containment facilities to handle high-potency drugs.

For all your potent drug contract manufacturing needs, contact Abbvie today.

It is essential to introduce the product inside the facilities during the next 3 to 5 years. This is because once the product is within the CDMO, it is hard to move to another CDMO. This is why suppliers having both manufacturing and development at the same location delivers a competitive benefit.

In addition, pharmaceutical companies prefer to partner with a well-integrated CDMO service provider proficient at high potent active pharmaceutical ingredient development from formulation to manufacturing. Today, there are an insufficient number of CDMOs who provide both Highly Potent Active Pharmaceutical Ingredients DP and DS.

Aseptic processing is a production method that can manufacture products that do not have bacteria or other contamination without subjecting the product to terminal sterilization processes. Several products degrade and lose their effect when subjected to the tough conditions of terminal sterilization.

Aseptic process manufacturing permits these products to be manufactured in a sterile environment, letting them maintain their usefulness while being safe to use on humans.

This article talks about the fundamentals of aseptic processing. Continue reading to learn more.

At AbbVie, we are number one when it comes to fill finish manufacturing. We deal on all kinds of pharmaceutical fill finish.

The Importance of Establishing Environment Controls for the Aseptic Process

All drug manufacturing, including terminal sterilization and solid oral dose manufacturing, must have environmental controls. This condition is addressed in cGMPs (Global Current Good Manufacturing Practices.)

The aim of these controls is to prevent product contamination that is caused by unsanitary conditions. The environmental controls to be scrutinized include, but are not limited to, microbial contamination and air pressure. These control limits are stricter for aseptic processing producers due to the nature of their business.

The Difference Between Terminal Sterilization and Aseptic Processing

The major difference between terminal sterilization and aseptic processing is when the step of sterilization happens in the process. In aseptic processing, the manufacturing process requires the product and any excipients, the stoppers, and the container to be separately decontaminated before being added to the sterile or cleanroom producing core, where the final product is produced in a highly controlled environment always monitored for potential microbial ingress and air quality.

In terminal sterilization, on the other hand, the manufacturing process is carried out after the stoppers, containers, excipients, and API have been assembled. The amassed product is thereafter exposed to radiation and/or high heat that causes the final product to become sterile.

The processes in terminal sterilization are harsh and can negatively affect the product's usefulness. Manufacturers opt for aseptic manufacturing for drug products that cannot withstand terminal sterilization.

Why is PUPSIT Required

Pre-use Post-sterilization Integrity Testing (PUPSIT) is a term used in aseptic processing operations. This testing is carried out on the sterilizing filter after it is installed before the product is manufactured and again after the product manufacturing is completed.

PUPSIT aims to ensure that the sterilization and installation process has not destroyed your filter before your product is filtered. It is also meant to show that the filter stayed intact and undestroyed during the real filtration of the drug product.

Why is Aseptic Drug Manufacturing Challenging?

Aseptic production requires experienced and highly trained experts to carry out the operations, constant environmental monitoring, cleaning procedures, and special equipment even when the production area is not in use. The risk to the patients and the product is great if the aseptic process is compromised.

At AbbVie contract manufacturing, we understand the importance of adhering to strict FDA standards. This understanding is one of the many reasons we are certified and FDA-registered. With this, our clients can be certain that they are working with an establishment that listens to their requirements and needs.

For drug manufacturers working on injectable medication, getting a new molecule to the clinic effectively and quickly is crucial; however, getting there with a safe product supply is also essential. Filling batches of clinical trial material is an important step in this process. Attention to a few major areas of this crucial pharmaceutical fill finish project can help prepare it for success.

Filling Clinical Trial Material

Before now, drug manufacturers spent quality time developing their molecules in a laboratory, manufacturing small volumes. In this phase of nurturing, the center is on understanding the molecule. However, two challenges are significant when it comes to in-human trial: developing a highly scalable, quality filling process that meets all quality and safety requirements and manufacturing significantly larger volumes to support a trial for in-human use.

The Four Steps Involved

Below are the four steps required in the preparation of medicine fill finish for clinical trial material;

1. Structuring a Proactive Plan

It takes time to successfully complete a first clinical batch project; it also takes more material than required just for clinical trials. It is recommended to always begin by setting up a schedule that permits all the extra steps that need to be taken and then make plans for a batch size that houses additional testing and analysis.

2. Organizing the Product

This is the perfect time to inform your CDMO partners and regulators more about the molecule, as this would help to ensure that it is ready for release to their test participants and clinical trials. Before your batch and IND are filed, crucial extra tests are needed to assess the stability, safety, and behavior outside the lab of the product.

3. Seeking the Right Expertise

Next, you want to start thinking about where and how you will find the multidisciplinary skills you require to excellently advance and execute your project; this includes process development, regulatory/CMC, project management, analytics, quality control/assurance, aseptic filling, and more.

You may want to procure CDMO partners and/or consultants like AbbVie contract manufacturing that can satisfy all the essential roles.

Employing the Best Practices

Fill finish clinical trial materials are usually the first time a new molecule is needed to be manufactured in a way that is in line with cGMPs, the nonstop growing standards that help ensure drug products are safe for use in humans. Conclusion

To be in line with the aforementioned best practices, your production process will require a quality system that incorporates three critical workflows.

* Qualification of the personnel and equipment which will be in charge of the product

* Endorsement of the processes that are used to fill it

* Documentation of all steps to regulatory standards

If you can partner with the best CDMO, they can play an invaluable role in helping you build that system.

Extrusion is the procedure involved in changing the physical properties of a substance by forcing it through a die or an orifice under controlled conditions. The equipment used in this process is classified into three major categories: screw extruders, radial screens, and ram. However, screw extruders are the most essential in the pharmaceutical industry. They are the most important because they constantly convert feed material to the finished form such as film, tube, or rod.

Continue reading this blog to learn more about screw extruders as one of the equipment used in the process of proprietary hot melt extrusion.

Screw Extruders

Pharmaceutical screw extruders are manufactured based on the desired extrudate. They are needed to meet the present regulatory standards for the production of dosage forms. They are categorized as:

* Single-screw extruders

* Twin-screw extruders

* Multi-screw extruders

Regardless of the type, process complexity, or function, the different extruders must be able to rotate the screw at a particular working speed while making up for the generated and torque shear rate from both the type of screw used and the material being extruded.

The Types of Extruders

Below are the types of Extruders:

1. Single-screw Extruder

The single-screw types are commonly used for conveying and melting polymers to extrude these polymers into incessant shapes. In comparison, twin-screw extruders are used to melt-mix polymers with extra materials and to devolatilize.

In manufacturing pharmaceutical formulations, which entail consistent and homogeneous mixing of several formulation ingredients, a twin-screw extruder is desired due to its rotation. The gyration of the inter-meshing screw delivers greater mixing to produce a homogeneous solid. This solid has finely dispersed active pharmaceutical ingredient particles or a solid solution of active pharmaceutical ingredients in the polymer.

2. Twin-screw Extruders

Constant melt-mixing through twin-screw extrusion can advance the bioavailability and dissolution rate of poorly water-soluble active pharmaceutical ingredient formulation. The evenly distributed active pharmaceutical ingredient is also a precondition to manufacturing drug-eluting devices with inter- and intra-batch reproducibility of drug-release kinetics.

Melting; a Process in HME

* Melting is achieved by heating frictionally in the barrel. In twin-screw extruders, on the other hand, the resources undergo shearing between the screws and the wall of the barrel and the rotating screws as they are conveyed. The barrel can be heated or cooled with water.

* The barrel section temperatures are commonly optimized so that the material viscosity isn’t high enough to allow proper conveyance down the barrel and mixing while also keeping temperatures low enough to avoid thermal degradation.

* In twin-screw extruders, the screws are commonly engineered to deliver varied types of conveying and mixing conditions at different zones in the barrel. During product manufacturing, modular screws with several elements fitted on a common shaft optimize and tailor the screw design for each product.

* Sections of the screw can be created to perform particle size mixing, reduction, and conveying functions. The length of the screw is chosen to optimize the number of zones and level of mixing required to achieve the final product characteristics.

Hot melt extrusion is the act of introducing pressure and heat to dissolve a polymer and make it go through an orifice in an ongoing process. Hot melt extrusion is a well-known processing method for polymers as far back as the thirties. With the evolution of technology, hot melt extrusion has found use in the healthcare industry, where it is used in many applications.

In this blog, we shall highlight the uses of proprietary hot melt extrusion in the pharmaceutical industry. Continue reading to learn more.

The Uses of Proprietary Hot Melt Extrusion

There are two most common reasons for using hot melt extrusion in the pharmaceutical world, highlighted and discussed below;

1. HME is Used to Improve the Bioavailability and Solubility of an API For BCS class II and IV active pharmaceutical ingredients, poor solubility is a result of a steady crystalline form that cannot be penetrated by water. The amorphous form of an active pharmaceutical ingredient is usually more soluble because not much energy is needed for dissolution.

This resulted in the development of solid dispersions to distribute the active pharmaceutical ingredient in a carrier polymer, inhibiting it from crystallizing.

Because hot melt extrusion involves continuous mixing, it is suitable for dispersing the active pharmaceutical ingredient into a polymer carrier. Feeding polymer and active pharmaceutical ingredients into an extruder cause extrudate that contains soluble, uniformly dispersed, and stable soluble.

2. HME is Used to Control the Delivery of an Active Pharmaceutical Ingredient Drug-eluting devices, also known as implantable drug-eluting systems, offer they can site-specific, localized drug delivery, thereby minimizing side effects and improving the effectiveness of the treatment.

These systems commonly provide active pharmaceutical ingredients over a long period to deliver continuous therapeutic effects with great patient compliance. This period can vary greatly depending on the product.

Whether a drug-eluting system requires to deliver for years or weeks, many of these products rely upon hot melt extrusion to disperse active pharmaceutical ingredients in a polymer matrix that delivers uniform, sustained drug release.

Conclusion Hot melt extrusion is a well-developed processing technique that can leverage process analytical technology. Hence, it is possible to highly reproducible and customized dispersions using this technique. Hot melt extrusion can produce drug-eluting systems with different release profiles, and this depends on the type of die that is used.

Simple extrusion of a solid profile produces matrix-type systems. These usually follow first-order kinetics release, commonly with an initial burst of the drug. On the other hand, reservoir systems may use a tubing die that is filled with the drug.

Some reservoir systems utilize a higher multi-layer extrusion method. Here, a core loaded with drug is, at the same time, extruded. These systems achieve almost zero-order release kinetics where the rate of drug-release does not change over time.

The highly-potent drug contract manufacturing industry continues to grow annually. The market for HPAPIs (highly potent active pharmaceutical ingredients), such as prostaglandins, anti-cancer drugs, opioids, and hormones, has a very high value.

Producing highly potent compounds involves extremely intricate, pricey facilities and processes. The compounds also come with high risks of contamination and toxicity. Because of these concerns, many pharmaceutical companies are partnering with contract manufacturing organizations. However, partnering with CMOs isn’t all it takes; finding the right expertise is the most important.

Handling Highly Potent Active Pharmaceutical Ingredients

Handling high potency active pharmaceutical ingredient formulations requires excellent and meticulous attention to detail, outstanding training, and a great understanding of the risks at every step of the manufacturing process.

This means that pharmaceutical manufacturing companies must take extreme care when choosing their contract manufacturing organization to partner with for HPAPI production. This is crucial to ensure that they are partnering with organizations that provide the best expertise.

There are many Positive Market Indicators in Potent Drug Contract Manufacturing

One of the top categories of high potency active pharmaceutical ingredients is oncology drugs. These drugs were already the most-valued therapeutic class of drugs in 2007. Here, $41.4 billion was accounted for, about 6.2 percent of the total global pharmaceutical market.

The sales of anti-cancer drugs such as cytotoxic active pharmaceutical ingredients have gone beyond double since then. About sixty percent of all the high-potency active pharmaceutical ingredients currently under development are focused on the cure of cancer.

However, cancer treatments are only a part of high-potency compound production. One of the most predominant trends in modern medicine is a slow but steady shift towards more potent, targeted treatments, which are biologically active in slight amounts. These treatments include lipids such as prostaglandins, therapeutic hormones, pain medicines such as opioids, and other highly potent active pharmaceutical ingredients for use in marketable compounds.

Pharmaceutical Companies are Investing in Potent Drug Contract Manufacturing

The increasing demand for these classes of drugs has raised 7 to 8-figure investments in high-potency active pharmaceutical ingredient contract manufacturing from leading pharmaceutical development firms worldwide.

The majority of these contract manufacturing organizations produce not only the highly potent active pharmaceutical ingredients themselves but also the ADCs (Antibody Drug Conjugates) that bond with the small molecules, helping to circulate them throughout the body and send them into targeted cells.

The Best Expertise in Highly Potent Drug CMO

Over the past few years, CMOS and pharmaceutical companies have greatly increased their investments in highly potent active pharmaceutical ingredients. CDO like AbbVie have spent millions on facilities for themselves as well as their subsidiaries.

Hot melt extrusion(HME) services have evolved as a unique processing technology in producing molecular dispersions of active pharmaceutical ingredients (APIs) into various polymer or/and lipid matrices, which has led to time-regulated, modified, extended, and targeted drug delivery. HME now allows us to use compounds to conceal the bitter taste of active drugs.

Since the industrial application of the extrusion process in the 1930s, proprietary hot melt extrusion has gotten a lot of attention from the pharmaceutical industry and academia for a variety of applications for pharmaceutical dosage forms like tablets, capsules, films, and implants for drug delivery via oral, transdermal, and transmucosal routes.

As a result, HME services are an ideal alternative to other commonly used processes such as roll spinning and spray drying which we make use of at Abbvie Contract Manufacturing. In addition to being a tried-and-true manufacturing process, meets the goal of the US Food and Drug Administration's (FDA) process analytical technology (PAT) scheme for designing, analysing, and controlling the manufacturing process through quality control measurements during the active extrusion process.

Advantages of Proprietary Hot Melt Extrusion

Proprietary hot melt extrusion has a number of benefits over currently used pharmaceutical processing methods, including

(a) Increased solubility and bioavailability of water-insoluble compounds: 

This is because binder components of HME dissolve easily in water, yielding the free soluble API inside the drug delivery matrix.

(b) Solvent-free nonambient process:

HME is a solvent-free process that is capable of producing the active pharmaceutical ingredient in an ambient process.

(c) Automation:

HME allows for quick and simple processing and manufacturing of dosage forms, which translates into higher yields and a shorter time to market.

(d) More economical:

The economic process with reduced production time, fewer processing steps, and a continuous operation is an advantage of HME.

(e) Capabilities of sustained, modified, and targeted release:

HME allows for the extended, modified, and targeted release of drugs for more specific drug delivery.

(f)  Better content uniformity in extrudates:

HME has a superior variability to other conventional uses such as spray drying. This is a major benefit since it allows for a more uniform content of the active ingredient because of the uniformity in the flow rate of material and the consistency of pressure distribution during extrusion.

(g) No requirements for compressibility:

This is due to its low operating pressure, which does not require a high vacuum.

Disadvantages of Proprietary Hot Melt Extrusion

Like everything that has an advantage, HME has certain downsides as well.

1. The heating process (drug and polymer stability): Since HME is a process that derives its energy from heat, it cannot be controlled as easily as other extrusion processes such as heat treatment or freeze-drying. This means that the API and active ingredient cannot be added to the polymer matrix during the extrusion stage.

2. The use of a restricted number of polymers: HME cannot tolerate many additives like in other processing methods such as spray drying, so HME is limited to a few polymers.

3. The high flow characteristics of polymers: HME is a process that pulls in the polymer through the pump; hence a high flow rate of material is inevitable.

4. Requirement of excipients that are not suitable for relatively high heat sensitive molecules such as microbial species and proteins are the primary limitations of HME.

A continuous process of melting a polymer under pressure and heat and forcing it through an aperture is known as hot melt extrusion (HME). We largely use Proprietary hot-melt extrusion at Abbvie Manufacturing.

Known for being created to create polymer goods with uniform shape and density, proprietary hot-melt extrusion has been used in industry since the 1930s.

We have some fun facts for you below about hot-melt extrusion

1. More than half of all plastic goods, such as bags, films, sheets, tubes, fibres, foams, and pipes, are prepared using this technology, which is one of the most commonly utilized in plastic, rubber, and food industries.

2. HME is now more commonly employed in the healthcare sector, where it is combined with polymers to create medical devices and combine active pharmaceutical ingredients (APIs) with them

3. Hot-melt extrusion services are utilized to increase the bioavailability of the API or to create the building blocks for thermoplastic drug-eluting devices such as intravaginal rings and subcutaneous and intraocular implants.

How does Proprietary Hot-Melt Extrusion work?

HME entails compacting and refining blends from a powder or granular mix into a uniformly shaped product. By forcing polymeric components and active substances, including any additives or plasticizers, through an orifice or die at controlled temperatures, pressures, feeding rates, and screw speeds, polymers are melted and formed into products of various shapes and sizes such as plastic bags, sheets, and pipes.

The entire HME services compaction process can be categorized into the following steps:

(1) feeding the extruder through a hopper,

(2) mixing, grinding, reducing the particle size, venting, and kneading,

(3) flow through the die, and

(4) extrusion from the die and subsequent downstream processing.

The extruder typically consists of one or two spinning screws inside of a stationary cylindrical barrel that is either corotating or counter-rotating. To reduce the amount of time molten materials must stay inside the barrel, it is frequently built in pieces. The barrel's sections are then bolted or fastened together. According to the shape of the extruded materials, an end-plate die is linked to the end of the barrel.

Types of Extruders

We generally use two types of extruders: single and twin screw extruders. Twin screw extruders are used for melt-mixing polymers with extra ingredients (pigments, fillers, reinforcers, and APIs), for devolatilization, and for melting and transporting polymers to extrude them into continuous structures.

A twin screw extruder is preferred for the creation of pharmaceutical formulations that call for the homogenous and consistent mixing of numerous formulation ingredients because the rotation of the inter-meshing screws improves mixing to create a homogeneous solid comprising finely dispersed API particles or a solid-solution of API in a polymer.

Poorly water-soluble API formulations can have their bioavailability and dissolution rate increased by using twin screw extrusion to consistently mix the melt. To create drug-eluting devices with reproducible drug-release kinetics within and within batches, uniformly dispersed API is also necessary.

Applications

Due to its many benefits over conventional processing techniques like roll spinning and grinding, HME technology has already established a solid presence in the pharmaceutical business and academics which we use at Abbvie Contract Manufacturing.

Proprietary hot melt extrusion has recently arisen as a revolutionary technology in pharmaceutical applications because, in addition to being an effective manufacturing process, it improves the quality and performance of made goods. HME is primarily used to molecularly disperse active pharmaceutical ingredients (APIs) in a matrix, resulting in solid solutions.

Hot-melt extrusion serviceshave been used in the pharmaceutical industry for a variety of purposes, including

Increasing the bioavailability and dissolution rate of poorly soluble drugs by creating a solid dispersion or solid solution.

regulating or modifying the drug's release.

masking the taste of bitter APIs

formulating different thin films

You might be surprised to learn that approximately a third of pharmaceutical production occurs in America. That is correct. From cell therapy to diabetic medications and biologics in the cold chain, American pharmaceutical corporations are increasingly outsourcing most medicinal product manufacturing.

Potent Drug Contract Manufacturing is now a multibillion-dollar industry and we have tapped into that industry. While it is an exciting moment for us to be in the clinical research industry, the expense of operations, the need to comply with regulatory regulations, and other considerations have grown difficult. Pharmaceutical manufacturing is highly complex, from research and development to commercial manufacturing.

What is Potent Drug Contract Manufacturing?

Contract manufacturing is essentially outsourcing a portion of the production process to an external company. The company you outsource to must meet stringent compliance standards and federal regulations. Outsourcing is also more cost-effective, as many companies already have the infrastructure and plants necessary for production.

Benefits of Potent Drug Contract Manufacturing

1. Cost Reduction

By outsourcing the manufacturing of certain medicinal products, you can reduce costs. Not only do you save on direct labor expenses, but you can save on overhead costs. It is common for pharmaceutical companies to outsource many of their medicinal raw materials and production.

This allows them to concentrate on cutting-edge research and development and improve the supply chain management systems needed to ensure product consistency.

2. Prioritization of Resources

Contract manufacturers have the expertise, as well as the staff, including chemists and other scientists, to provide mass production of drugs. This allows pharmaceutical companies to focus on high-end research and development projects. The money and resources saved by contract manufacturing can be diverted to other operations.

 Using the saved funds, a company can, for example, improve its marketing techniques, add personnel for other departments, and/or strengthen sales efforts.

3. Improved Manufacturing Time

Number 3 benefit ofPotent Drug Contract Manufacturingis improved manufacturing time. Manufacturing companies in the U.S. have established efficient processes and are quickly adapting to changes in production.

When you outsource to a contract manufacturing company, it allows you to focus on other phases of production hence shortening the time spent on manufacturing a drug, which increases profits and overall efficiency.

You must work with experts who can provide immediate solutions and solutions that keep your production process on track.

4. Easier Market Entry

By outsourcing to contract manufacturing companies, you have an easier time getting drugs on the market. Pharmaceutical companies often struggle to meet regulations and maintain a high manufacturing standard.

By having the contract manufacturer manufacture your drug under the same regulations as American companies, it is easier for your drug to be approved in the U.S. This increases consumer access to drugs. This is a huge perk, especially as more consumers look to pharmaceutical drugs to help them live healthier lives.

What are the Challenges of Potent Drug Contract Manufacturing?

The major challenge of potent drug contract manufacturing is ensuring the drug's safety during production. This can be accomplished by engineering a rigorous manufacturing process that reduces the risk of contamination.

The contract manufacturer must then be able to submit the drug for testing and approval for it to be released under the same process as products manufactured by American companies.

The growing field of medications poses a distinctive set of challenges and safety concerns. As a result, pharmaceutical companies must ensure the safety of drugs during production and scale up production to commercial levels throughout all distribution channels.

Due to the large production of these drugs, pharmaceutical companies may be unable to keep up with producing these drugs in large quantities. Hence the need to contract it out to potent drug contract manufacturing companies like ours; Abbvie Contract Manufacturing.

Meaning of Potent Drug Contract Manufacturing

Potent drug contract manufacturing is a process of making potent pharmaceutical drugs on demand. Potent drug contract manufacturing companies like Abbvie provide services such as producing different kinds of drugs and medicines of high quality in large quantities and at competitive prices. This means that the production of these drugs will be under the control of a third party.

We offer a wide range of activities for pharmaceutical and biotechnology companies. Potent drug contract manufacturing is seen as a great way for pharmaceutical companies to cut costs and increase their profit margins. Nothing is done without motivation; as such, there are several reasons why pharmaceutical companies outsource their production.

Benefits of Potent Drug Contract Manufacturing

1. Potent Drug Manufacturers are experts in the field.

One of the main benefits of using potent drug contract manufacturing companies is this. They are experts in the manufacturing of these drugs. When you outsource to them, you are sure of quality in terms of production.

2. They have Specialized Facilities and equipment.

Potent drug contract manufacturing companies have specialized, high technological equipment that is used to manufacture these drugs. When pharmaceutical companies outsource to these potent drug contract manufacturers, they tend to access the outsourcing company's technical know-how, which they may not possess.

3. Potent Drug Contract Manufacturers Ensure the Large Production of Drugs

This is another benefit of using potent drug contract manufacturers. They ensure that drugs needed in large quantities are produced and accessible to users. So they help the pharmaceutical companies to meet up with their production target.

4. Clients Get Drugs at Competitive Prices

Due to the presence of these contracts, the customers get access to drugs at affordable prices. This is because they can get these drugs at a lower price than their product.

5. They Have Lesser Production Costs

This is one of the reasons why clients prefer potency contract manufacturing. These companies offer to produce these drugs for clients at reduced prices with quality assurance.

6. High Quality of Drugs

One of the best experiences of using potent contract manufacturing is that quality is assured. Most potent drug contract manufacturing companies use high technologies and equipment to produce these drugs. As a result, there is assurance that the drugs will be up to your expectations.

Hot melt extrusion (HME) is the technique of heating polymeric materials far beyond their glass transition temperature (abbreviated Tg in pharmaceutical production circles) to achieve molecular level mixing of active compounds, polymers, and thermoplastic binders. HME is a mix of mechanical and melting energy that is used in a variety of sectors to improve continuous processing for dust reduction, online monitoring, and reproducible material analysis.

HME services are applied in pharmaceutical production to diffuse APIs in a matrix at the molecular level for the purpose of getting solid solutions. This allows for the development of drug delivery methods for poorly soluble medicines or specialty drug forms such as antidiabetic drugs and transdermal patch films.

Today, hot melt extrusion has an exalted position in pharmaceutical production and is used to make a variety of medication forms such as implants, granules, pellets, prolonged release tablets, and ophthalmic inserts. Polymers may be molded into a film by hot melt extrusion, eliminating the need for traditional solvent-casting procedures.

The pharmaceutical industry's focus on hot melt extrusion is primarily on the creation of bio-enhanced formulations, mass production of medications in the form of pellets, beads, and transdermal systems, and the formation of solid solutions from water soluble pharmaceuticals. This highlights hot melt extrusion as having advantages over more typical drug production procedures, but not without some cons.

Pros and Cons of HME Services

When it comes to pharmaceutical manufacturing, hot melt extrusion has several benefits over traditional drug manufacturing methods. Below are these pros and cons:

Pros

There are fewer procedures involved, along with the elimination of drying steps, which boosts productivity and saves time. The procedure is straightforward and may be carried out uninterruptedly and efficiently.

Because of the high temperatures and powerful mixing that ensue during the production process, active chemicals are more uniformly distributed in the polymer, resulting in higher bioavailability.

Hot melt extrusion allows for the production of a broad range of dosage forms, which is one of the main reasons why contract manufacturing pharma businesses are adopting the method on a larger scale.

When compared to traditional processes, the advantages clearly make this method of production enticing, but it is not without its problems.

Cons

Because it is a thermic process, there may be problems with the API/polymer stability. The flow characteristics of the polymer are critical in effective processing, and heat manufacturing can occasionally be a concern during the process.

The required number of polymers may be limited due to the fact that getting polymers that can be treated at low temperatures for this process can be difficult.

Looking For Quality Contract Pharma Services? AbbVie is here to meet those needs

AbbVie is a contract pharmaceutical manufacturer specializing in controlled release technologies such as fluid bed processing and hot melt extrusion (HME).

AbbVie Contract Manufacturing advances your science with proprietary hot melt extrusion technology and services.

AbbVie offers different kinds of customized and proprietary hot melt extrusion services such as:

• End-to-end manufacturing from extrudate to packaged drug product.

• Expertise in bioavailability enhancement

• Solvent-free and continuous processing

• Support for good process control and scalability

• Abuse deterrent and taste masking capabilities.

HME is a solvent-free production method that improves the bioavailability of poorly soluble and powerful APIs. HME is less expensive than other formulation choices due to continuous processing and may be utilized for taste masking. This can result in a higher-quality, more marketable product consistent with your marketing strategy.

In this article, we will be looking at the polymers used, the technology involved, and the process parameters in HME services.

Polymers Used in Hot Melt Extrusion

In HME, selecting an appropriate polymer as a matrix to produce stable solid solutions is critical. Polymers with a high solubilization capacity are ideal because they can dissolve huge amounts of drugs. Polymers for HME experimentations are composed of various chemical structures and monomers, including copolymers, amphiphilic copolymers, homopolymers, and plasticizers and solubilizers.

The polymer's solubility in a solvent, ranging from high hydrophilicity to high lipophilicity, must be considered for each substance. For the manufacture of solid solutions by spray drying, a suitable solvent must be used, where polymer and medication must be dissolved in a volatile solvent.

Polymers for hot-melt extrusion must be thermoplastic and thermally stable at the appropriate extrusion temperature. Also, glass transition and melting temperatures are essential criteria in developing an HME medication system. Tg or Tm and melt viscosity are the primary determinants of a polymer's extrudability. Most polymers display thixotropic behavior, where viscosity decreases as shear force increases.

Pharmaceutical Extrusion Technology

The current drug development technique generates candidate medications with increasing lipophilicity and molecular size, resulting in poor permeability and solubility. Less than ten percent of novel drug candidates display both high solubility and permeability, while about thirty to forty per cent of medications on the World Health Organization Essential Drug List have been observed to be poorly water-soluble or lipophilic. HME diffuses the medication in the matrix at the molecular phase by producing a solid solution.

HME is used in a variety of applications such as controlled release systems, amorphous solid dispersion, innovative cocrystallization (solvent-free continuous cocrystallization), polymorph production, porous polymeric systems, and Process Analytical Technology (PAT).

Process Parameters for HME Processing

During the HME process, the active pharmaceutical ingredient and excipients are introduced into the extruder. All components are sheared, fired up, plastified, blended and distributed before being formed by squeezing them through a die aperture.

When developing an HME manufacturing project, controlling many processing factors that impact residence time distribution is required, and specific mechanical energy consumption (SMEC), such as melt temperature at the extruder die, pressure at the die, and torque must be considered.

Conclusion

AbbVie is a pharmaceutical contract manufacturing company offering proprietary hot melt extrusion services suitable to your specific product and marketing strategy.

AbbVie offers different kinds of proprietary hot melt extrusion services, such as:

• End-to-end manufacturing from extrudate to packaged drug products.

• Expertise in bioavailability enhancement

• Solvent-free and continuous processing

• Support for good process control and scalability

• Abuse deterrent and taste masking capabilities.

You might be surprised to learn that approximately only a third of pharmaceutical manufacturing is done internally. Most potent drug contract manufacturing companies are now outsourced by American pharmaceutical companies, from cell therapy to diabetes medications and biologics. Contract pharmaceuticals are now a big business. Although this is an exciting time in the drug development industry, other variables, such as operating expenses and the need to comply with regulations, are fast becoming problematic. The reason is that the process of making pharmaceuticals, from research and development to commercial manufacture, is highly complex.

A pharmaceutical business that offers drug development and manufacturing services is known as a contract development and manufacturing organization (CDMO). By partnering with CDMOs, pharmaceutical companies can outsource medication development and production.

Functions of CDMOs

Full-service CDMOs can take on every drug development and manufacturing phase and liaise with clients looking to outsource specific components. It all rests on what each client desires.

Some of the services provided by CDMOs are:

Formulation

Analytical Services

Blending

Coating

Converting

Packaging

Serialization

Shipment

A pharmaceutical business can collaborate with a full-service CDMO with just an idea and be directed through pre-formulation and formulation development, clinical trials, and commercial production.

What Differentiates CDMOs from CMOs?

Development distinguishes a contract development and manufacturing organization (CDMO) from a contract manufacturing organization (CMO). Unlike CDMOs, which handle the development and manufacturing of medicine, CMOs manufacture drugs that have already been pre-formulated.

What Are The Advantages Of Cdmos?

Below are some advantages of CDMOs:

● Know-How

A full-service CDMO offers an astounding range and depth of expertise and specialization. It makes sense for CDMOs to invest in talented researchers, chemists, and development specialists, given their industry's core strength. After all, the most prosperous people are those who can give pharmaceutical corporations the insight, control, and creativity they need.

● Equipment and Facilities

Equipment is another area where top CDMOs invest. Pharmaceutical businesses have a difficult choice to make when they wish to increase capabilities, release a new drug, or manufacture at a different rate with internal drug development and production. All of those choices involve expensive capital expenditures.

On the other hand, outsourcing to a CDMO allows businesses to access large-scale facilities and equipment without incurring the cost of ownership.

● Scalability

Pharmaceutical businesses frequently rely on CDMO producers to help them scale (mostly upwards). For pharmaceutical corporations, changes in production volume or the inclusion of a new medicine variant might carry a very high risk. However, these choices have a lot less risk and shorter lead times when made as part of CDMO cooperation.

Pharmaceutical development and production outsourcing help companies of all sizes grow. Pharmaceutical companies of all sizes may operate more cost-effectively because they know that the costs of developing and producing new drugs can cause them to break the bank.

Conclusion

The pharmaceutical sector, which is expanding swiftly, keeps exploring innovative ways to promote more FDA-approved pharmaceutical goods efficiently and quickly. It is anticipated that during the coming years, the significant outsourcing of therapeutic product development and production by CMO contract businesses will continue or perhaps pick up speed.

Strategic alliances between pharmaceutical firms and potent drug contract manufacturing companies frequently drive rapid expansion of the pharmaceutical industry. The market for potent API manufacturing is still developing, and it depends on pharmaceutical technology to meet client needs. To ensure patient safety and medicine quality, potent drug contract manufacturing businesses must follow cGMP standards for sterile facilities, manufacturing procedures, formulation research, etc.

New compounds are becoming increasingly more selective in their pharmacological activity and a trend in drug discovery. Concerning the safe handling of the compounds and achieving dosage repeatability, the production activities involving potent drug contract manufacturing are becoming more challenging.

As a result, lots of businesses opt to outsource contract development and manufacturing organizations (CDMOs) with the required expertise and resources to develop and produce highly potent medications on their behalf.

But if someone wants to contract out the formulation development of a highly potent medicine, what qualities should they seek in a CDMO?

Criteria to consider when selecting a CDMO to develop highly potent formulations

The following criteria should be considered when choosing whether to outsource a potent drug contract manufacturing:

1. Expertise

Finding a good drug content uniformity per unit dose is sometimes the most challenging. Therefore, a component that needs to be considered is the CDMO's history of creating low-dose formulations.

From the initial development of a drug formulation through the clinical process, the personnel in charge of the project should be questioned about their experience and technical expertise.

Also, suitable training protocols must be in place to safely handle potent compounds throughout clinical manufacturing.

2. Capability for processing

Potent drug contract manufacturing formulations frequently include only a few milligrams of medication and occasionally even just a few micrograms. Consideration should be given to the medicine being dissolved in a liquid carrier and put into capsules for shallow dose requirements.

A key factor to consider is if the potential CDMO has the necessary development skills and processing capability to make such low-dose goods.

When outsourcing a formulation development project to a third party, most vendors prefer the CDMO to be responsible for providing products for clinical trial use.

To ensure that the CDMO can scale up operations from benchtop to early-phase cGMP production. In reality, most CDMOs will have a full scale they can create depending on the equipment's capabilities, the facility's adaptability, and the availability of resources. If the project continues to grow, talk with your CDMO about future tech transfer and scale-up alternatives.

3. Project administration

Even if a CDMO appears to have the necessary combination of knowledge, expertise, and processing power, it does not imply that your project will be in good hands.

Project management is one factor that can significantly impact an outsourced development program's success (or failure). Ask the CDMO how projects are routinely accepted, managed, and finished. Also, ask who the project team members will be and your point of contact.

To ensure you are both on the same page, work closely with your CDMO to establish an outline of how the contract partner sees the work program broken down and how each stage will be scheduled. To assist management expectations, decide in advance on the channels, timing, and frequency of communication.

Conclusion

Hot Melt Extrusion (HME) has captivated the pharmaceutical industry for the manufacture of medicinal solid dispersions over the last decade. It's a flexible processing method for increasing the solubility and dissolution of water-insoluble active therapeutic components (APIs). HME services are superior to traditional formulation technologies because they can treat a wide range of ingredients, including inorganic excipients, hydrophilic polymers, and cocrystal formers. In this review study, we explore recent advances in enhanced solubility/dissolution of water-insoluble actives utilizing HME and prediction tools for process optimization.

Proprietary Hot-melt extrusion, a well-known method in the polymer industry, is making its way into pharmaceutical manufacture. HME enables novel solid oral dosage form formulations.

Its primary benefit in pharmaceutical applications is the potential to improve a drug's bioavailability by producing solid dispersions of the dynamic pharmaceutical ingredient (API) in a polymer matrix. The formulator's primary focus is achieving the right release profile (immediate or prolonged release) or increased API bioavailability.

HME services have shown unique processing technology for creating molecular dispersions of active pharmaceutical ingredients (APIs) into the various polymer or lipid matrices, allowing for time-controlled, extended, modified and targeted drug supply.

HME has received significant attention from both the pharmaceutical industry and academia in various submissions for pharmaceutical dosage forms such as tablets, capsules, films, and implants for drug delivery via oral, transdermal and transmucosal routes since the industrial application of the extrusion process in the 1930s.

As a result, HME service is an excellent alternative to other often-used processes like roll spinning and spray drying.

HME fits the purpose of the US Food and Drug Administration's (FDA) process analytical technology (PAT) system for designing, analyzing, and controlling the manufacturing process via quality control measures during the active extrusion process, in addition to being a proven manufacturing method. The hot-melt extrusion technique is discussed from a holistic standpoint, including its numerous components, processing technologies, materials, and innovative formulation design and developments in its various applications in oral drug delivery systems.

Advantages of HME

There are specific issues with HME. Thermal process (drug/polymer stability), usage of a restricted number of polymers, high flow characteristics of polymers, and excipients required are the main disadvantages of HME, which make it unsuitable for relatively high heat-sensitive molecules like microbial species and proteins. However, HME has several advantages over currently existing pharmaceutical processing procedures, including the following:

(a) Improved solubility and bio-availability of liquid-insoluble compounds;

(b) Solvent-free-non-ambient process;

(c) A cost-effective process with condensed production time, fewer processing steps, and constant operation;

(d) Sustained, modified, and targeted release capabilities;

(e) Better content uniformity in extrudates;

(f) No necessities for active ingredient compressibility;

(g) Uniform dispersion of fine particles;

(h) better steadiness at altering pH and moisture levels and safe application in mankind;

(i) Fewer unit procedures and the manufacture of a diverse variety of performance dosage forms

(j) Various screw geometries.

Conclusion

HME has proven to be a reliable way of manufacturing a variety of drug delivery systems; therefore, it has been adopted by the pharmaceutical industry, with the scope expanded to include a variety of polymers and APIs that can be processed with or without plasticizers. HME has also been demonstrated to be a solvent-free, robust, fast, and cost-effective manufacturing process for various medicinal dosage forms.