Antibody Drug Conjugates (ADC)

Antibody Drug Conjugates (ADC)
Product Description

hen selecting AbbVie Contract Manufacturing, you are partnering with a leading developer and manufacturer focused on accelerating and mitigating risks to program timelines and on efficiently fast-tracking your program to completion. AbbVie’s mAb and ADC state-of-the-art facility and expert scientific team are located in Worcester, Massachusetts, where we specialize in treating your product as our own and have demonstrated the capability to optimize success from innovation through commercialization. In addition to our expertise, our customers also benefit from a simplified supply chain as both mAb and conjugation manufacturing are conveniently located at one site.

AbbVie Contract Manufacturing

  • US
  • 2015
    On CPhI since

AbbVie Contract Manufacturing

  • US
  • 2015
    On CPhI since

More Products from AbbVie Contract Manufacturing

  • Aseptic Fill Finish

    Product Aseptic Fill Finish

    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.

  • Custom API

    Product Custom API

    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.
  • Drug Product

    Product Drug Product

    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)

    Product Hot Melt Extrusion (HME)

    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

    HOT MELT EXTRUSION PROCESS 
    Using proprietary hot melt extrusion technology, AbbVie has successfully developed, scaled-up and commercialized many challenging chemical entities. The process involves distributing active pharmaceutical ingredients (APIs) through a specialized matrix to form a solid solution with known potency. Through this, hot melt extrusion can improve both drug efficacy and drug delivery efficiency. AbbVie Contract Manufacturing can then package your compound in a range of commercial dosage forms, including: Tableting/encapsulation, Potents (small concentrations), Controlled and modified release
  • Fermentation

    Product Fermentation

    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
  • Biologics Development and Manufacturing

    Product Biologics Development and Manufacturing

    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.

    AbbVie Contract Manufacturing offers exceptional end-to-end biologics capabilities with some of the world’s most advanced production facilities. As a leading biologics CMO, we offer the following expertise and more: 

    Cell line development, Process optimization, Fermentation biotechnology, Analytical characterization, cGMP manufacturing, Validation
  • Potent

    Product Potent

    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 
    To minimize risk at every phase, AbbVie Contract Manufacturing first works to comprehensively characterize your compound, determining its occupational exposure band (OEB) hazard rating and implementing any necessary safety steps. With this knowledge, we can help you develop optimal manufacturing processes, clinical trial designs and drug delivery methods. Through core facilities, such as our Sligo, Ireland site, we offer contract manufacturing for cytotoxic drug products with potency classification as low as OEB 5 (<1 μg/m3).

  • Prefilled Syringe

    Product Prefilled Syringe

    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 
    AbbVie Contract Manufacturing offers a continuous workflow for a range of prefilled syringes, packaging and supply options, including:  Disposable syringe manufacturing, Safety syringes, Sterile injectables and Prefilled syringe packaging. 

    ABBVIE ASEPTIC FILLING 
    With the use of sophisticated fill finish techniques and equipment – including Restricted Access Barrier System (RABS) technology – AbbVie Contract Manufacturing brings total efficiency to the full syringe manufacturing workflow. Our competitive advantage comes through a combination of people, processes and tools, including:

    An aseptic filling suite utilizing RABS technology, Filler utilizing peristaltic pump technology, Fill volumes from 0.4 mL – 8 mL (in BD Hypak or equivalent type syringe utilizing the SCF Format), 100% visual inspectionCompatible with closures packaged in rapid transfer port systemCold chain warehousing and On-site microbial laboratory, chemistry and testing.
  • Erythromycin Base

    Product Erythromycin Base

    For more information contact AbbVie Contract Manufacturing
  • Erythromycin Ethylsuccinate

    Product Erythromycin Ethylsuccinate

    For more information contact AbbVie Contract Manufacturing
  • Erythromycin Stearate

    Product Erythromycin Stearate

    For more information contact AbbVie Contract Manufacturing
  • Erythromycin Thiocyanate

    Product Erythromycin Thiocyanate

    For more information contact AbbVie Contract Manufacturing. 

AbbVie Contract Manufacturing resources

  • Brochure AbbVie CMO Services

    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

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