Antibody Drug Conjugates (ADC)

We offer two convenient fill-finish options for parenteral drug products: prefilled syringe and vials. As a leading pharmaceutical partner, we can provide all necessary elements of delivering high-quality parenteral products for clinical and commercial needs.

AbbVie will leverage its know-how and proven quality, regulatory, and operational network to help you achieve your milestones through comprehensive development and manufacturing support for your vial and syringe drug product formulations.

AbbVie’s API site has the flexibility to run multiple chemical processes simultaneously to support late development phase to commercial products including highly potent drug containment up to OEL 3A (1 µg/m3). State of the art QC laboratories integrated across a highly experienced team focused on commercial readiness and manufacturing expertise are available to support technical transfer and life cycle management activities. AbbVie also offers our partners extensive CMC, QA and regulatory know-how with a proven track record resulting in a seamless technology transfer and assured success in validation and ongoing commercial supply.

Whether you’re developing a new chemical entity or a first-to-market generic, precise dosing and drug delivery is vital for success. Regulatory agencies and clinicians want to see well-characterized, reliable doses with good bioavailability. Patients/consumers often favor a controlled release dosage form, with easy-to-use packaging and taste-free consumption. To manage a successful pharmaceutical program, drug developers increasingly need to deliver on all these fronts and more, without compromising speed-to-market.

With a network of experts, supply chains and seven facilities across North America and Europe, AbbVie Contract Manufacturing can extend your capabilities, efficiency and reach.  Our services support material procurement, process optimization, formulation, validation and analytics testing. 

Hot melt extrusion (HME) is a proven technology for bioavailability enhancement of poorly soluble API's. Unlike other formulation options, hot melt extrusion technology is solvent-free. By drawing on continuous processing, it is also more economical and can be used for abuse deference and taste masking applications. This can ultimately deliver a higher quality, more marketable pharmaceutical product — in line with your commercialization strategy.

AbbVie advances your science like we would our own, with customized hot melt extrusion services that include:
Solubility/bioavailability enhancement, Support for good process control and scalability, Taste masking capabilities and Proven expertise in drug delivery

Fermentation is a critical step in both drug and toll manufacturing, as companies look to produce the core compounds that form their eventual products. While it is possible to undertake this in-house, the expertise contract fermentation services provide can improve the quality, affordability, speed and scalability of your program.

Pharmaceutical and Toll Manufacturing With more than 60 years of leadership in the field, AbbVie Contract Manufacturing offers fine-tuned contract fermentation services. We bring the same degree of expertise and passion to your project as we do with our own, supporting you from strain development through to large-scale commercial manufacturing.

AbbVie’s contract fermentation services span many organisms, stages, industries and production volumes. These include:
Strain development, Microbial fermentation, Yeast fermentation, Large-scale contract fermentation, Fermentation process validation, Distribution support and Secure manufacturing supply

With patients’ lives at the end of the pipeline, biologics contract manufacturing needs to be safe, reliable and be consistent in supply. The developers of these large molecule drugs, however, are also operating in a highly competitive space. Speed-to-market is imperative, along with efficient processes and low costs. A lot of this will rest on the quality of the cell line development and the expertise of the biologics CMO you choose.

AbbVie Contract Manufacturing has a proven track record in biopharmaceutical process development and is committed to treating your project as if it were our own. We understand the importance of strong partnerships with our customers and the need for confidence in our team. AbbVie maintains one of the most trusted reputations in the industry and is known for reliability, flexibility, and scientific expertise.

High potency manufacturing is an expanding field with a unique set of challenges. Safety remains a primary concern for those handling cytotoxic drug products, as well as the clinicians and patients down the line. Beyond safety, pharmaceutical companies need to plan ahead for how they will manufacture high potency drugs at scale, distributing the end-products worldwide with secure supply chains in place.

AbbVie Contract Manufacturing’s people, processes and facilities encompass the highest Environmental Health and Safety (EHS) industry practices for handling potent compounds. With a clear understanding of your compounds occupational exposure band classification and proven expertise, AbbVie can help you achieve the most efficient and sustainable cytotoxic drug manufacturing workflow.

Occupational Exposure Band (OEB) Considerations 

Fill-finish syringe manufacturing is one of the last steps in pharmaceutical commercialization. The goal here is efficiency and sterility. Companies don’t want to waste any of their carefully developed product and they don’t want to distribute poor quality prefilled syringes or contaminated formulas. Once established, high syringe manufacturing standards must then be maintained throughout the drug’s life span, to deliver a reliable supply for patients.

With advanced fill-finish technology and a specialized facility in Barceloneta, Puerto Rico, AbbVie Contract Manufacturing performs this final development step with high-tuned efficiency. Aseptic filling is done within purpose-built machines that maximize product volumes, while decreasing contamination risk and human variables. For added security, AbbVie experts then undertake rigorous analytical screening and quality control. Through this, customers gain access to the world’s most advanced syringe manufacturing processes, people and facilities, with a global network geared towards security of supply.

PREFILLED SYRINGE CAPABILITIES 

For more information contact AbbVie Contract Manufacturing

For more information contact AbbVie Contract Manufacturing

For more information contact AbbVie Contract Manufacturing

For more information contact AbbVie Contract Manufacturing. 

AbbVie’s Contract Manufacturing business has been serving our partners for more than 40 years. Our contract development and manufacturing capabilities span across 11 production facilities in North America and Europe. Our capabilities are: Aseptic Fill Finish (Vial and Prefilled Syringe) Custom & Bulk API Manufacturing Oral Solid Dose Fermentation Hot Melt Extrusion Potent Biologics Packaging