AbbVie CMO: Your Expert Partner in Bringing Biologics to Market
By: John Casey, Director, Biologics Contract Manufacturing, Jon Best, Director, Business Development
The process of developing and manufacturing a monoclonal antibody (mAb) therapeutic can be overwhelming. With numerous variables impacting product quality, many organizations developing these complex molecules require proven expertise and support to timely deliver a safe, reliable therapeutic that meets patient needs.
By choosing AbbVie, you’re partnering with a highly experienced and trusted organization that has brought many Biologics to market. Much more than a CMO, AbbVie is an established biopharmaceutical partner to provide comprehensive support at every phase of your mAb’s development to commercial life cycle.
With a long-standing track record in biopharmaceutical process development, a knowledgeable scientific team, world-class global facilities, and exceptional end-to-end Biologics capabilities, AbbVie has a comprehensive platform to support the development, manufacture and commercialization of your Biologics therapeutic. Robust quality systems are in place to assure consistent, high quality supply, providing you with confidence in milestone achievement. Moreover, our total commitment to treating your program as if it were our own ensures strong collaboration and ultimate success all the way from innovation to commercialization.
AbbVie’s comprehensive Biologics service portfolio includes:
- Master and Working cell bank generation
- Media development and optimization
- Cell culture process development
- Purification process development
- Analytical method development and validation
- Process transfer
- Extended product characterization
- Process characterization and Process Performance Qualification
- cGMP clinical to commercial manufacturing
- Viral clearance studies
These capabilities are supported by structured and responsive project management, recognized expertise in global marketing approval and regulatory filing, and the capacity to successfully manage multiple projects simultaneously. Choosing AbbVie CMO provides solutions around not only assurance of supply, but also a trusted long-term partner that puts your needs foremost.
Operating from multiple locations worldwide, AbbVie Biologic’s center of excellence is conveniently located just outside of Boston in Worcester, Massachusetts. This primary bioresearch and manufacturing site is complemented by manufacturing centers in Puerto Rico and Singapore, making up some of the most technologically advanced facilities in the world. Our sites offer global pharmaceutical companies a high degree of flexibility, scale, and wide-ranging capabilities to support every stage of mAb development and manufacture.
The development and manufacture of your mAb will begin in Worcester, Massachusetts at the AbbVie Bioresearch Center (ABC). The ABC site is licensed as a multi-product facility, with five independent cGMP suites operating at different scales (2 x 1000L – 3 x 6000L). Distinct processing areas are defined for cell culture, purification and bulk fill, and each production suite is serviced by a separate air handling unit. The plant benefits from onsite water for injection production, clean steam, autoclaves, and sufficient freezer capacity to support the entire facility. Disposable technology options can be incorporated throughout your process, minimizing requirements to validate cleaning processes and reducing the risk of cross-contamination.
Detailed, up-to-date regulatory inspection reports are available for any of our facilities, along with all the supporting documentation pertaining to the utility, process and quality systems of each site.
Robust process development and optimization
Process development at AbbVie is performed by highly experienced and tenured personnel. With a strong focus on cell culture, purification, and analytical method development / characterization, our process development teams are sub-divided into closely aligned, collaborative groups each performing critical development activities across respective programs:
Cell culture / purification groups
- Preparation of development candidates
- MCB/WCB creation and testing (extensive experience with CHO and NSO cell lines, and multiple expression systems)
- Media development and optimization
- Process development and technology transfer
- Process characterization and validation studies
- CMC support (viral clearance, impurity clearance, column lifetime studies)
Protein analytics group
- Biochemical and biophysical characterization of biotherapeutics
- Characterization of development candidates
- Analytical method development
- Assay development and transfer to QC
- Extended product characterization and comparability studies
- Process development and manufacturing support
Process development timelines can be expedited using appropriately sized small-scale models to define and optimize each stage of mAb production process. Through rigorous testing, we have qualified these models as representative of large-scale performance and demonstrated our development processes to be exceptional in their scalability thereby saving both time and money during development and scale up processes.
Analytical methods tailored to the mAb life cycle
We perform an extensive range of analytical testing that includes optimization and validation of methods to meet the varying requirements of the mAb life cycle. During process development and process characterization, the analytical assays applied to product quality monitoring include:
- Size Exclusion Chromatography (SEC)
- Cation Exchange Chromatography (CEX)
- Imaged Capillary Isoelectric Focusing (icIEF)
- Capillary Electrophoresis Sodium Dodecyl Sulfate (CE-SDS) or microfluidic Capillary Electrophoresis (mCE)
- Released glycan analysis
- Hydrophobic Interaction Chromatography (HIC)
- Liquid Chromatography-Mass Spectrometry (LC/MS)
- Host Cell Protein ELISA
- Residual Protein A by ELISA
- Antigen-binding ELISA
- Surface Plasmon Resonance (SPR)
Process characterization assays are selected for QC lot release, along with LC-UV peptide map method, bioassay and compendial assays. The capability exists to also perform a comprehensive list of assays for extended characterization and comparability study. mAbs are characterized at the primary, secondary, tertiary and higher order structure level with a variety of biophysical techniques such as:
- LC/MS for intact and reduced MW
- Non-reducing and reducing LC-MS/MS peptide mapping
- Differential Scanning Calorimetry (DSC)
- Far- and near-UV circular dichroism (CD) spectroscopy
- Free sulfhydryl (SH) analysis
- Analytical Ultracentrifugation (AUC)
- Surface Plasmon Resonance (SPR) for FcRn binding
To ensure that a full validation per ICH guidelines is completed by Phase III, we qualify and validate test methods using a proven phase-based approach. By increasing the level of validation as your mAb progresses through clinical trials, we assure continued product quality and avoid potentially costly delays.
An open approach to sharing information
At AbbVie CMO we pride ourselves on treating your therapeutic mAb as if it were our own. This means that we consider all raw data to be your property and will make this data available to you at any time. But why not take advantage of our expertise in arranging exactly which data and reports you will need at each stage of your mAb’s journey? Your dedicated project manager can help you to deliver everything necessary to meet regulatory requirements, thereby eliminating the potential for delays due to missing or incorrect information.
Technology transfer methodology with 100% success rate
Often, mAb developers choose to partner with AbbVie CMO once significant work has been carried out in-house. To streamline technology transfer from your site to ours, we have developed a methodology that has resulted in 100% success rate. Although technology transfer timelines will largely depend on the degree to which your process has been defined, we have vast capability in process development and can easily fill any gaps where documentation is currently unavailable.
A trusted partner for your mAb therapeutic
By choosing AbbVie CMO for development and manufacture of your mAb, you’re not only selecting a CMO, you’re selecting a pharmaceutical partner. In making this choice, you will benefit from the scientific expertise of a company with a proven track record in biopharmaceutical process development, manufacturing and commercialization. Delivering exceptional end-to-end Biologics capabilities from state-of-the-art facilities, we operate globally to support every stage of your mAb’s life cycle. And with one of the most trusted reputations in the Biologics CMO industry, it’s clear that we create partnerships which deliver innovative medicines and make a remarkable impact on people’s lives.
To learn more about how AbbVie CMO can support the development and manufacture of your mAb, contact us at 1-847-938-8524 or visit www.abbviecontractmfg.com for more details.