- Monoclonal antibodies (mAb)
- Fusion Proteins
- Bispecific & trispecific antibodies
- Antibody drug conjugates (ADC)
AbbVie offers extensive scaleup and commercial expertise for cell culture biologics, including clinical and commercial excellence in monoclonal antibodies (mAb) production, fusion proteins, bispecific & trispecific molecules, antibody drug conjugations and other complex proteins.
As a global leader in patient care, we offer risk mitigation strategies and careful, balanced project scheduling to ensure a secure and reliable patient supply chain, from cell line to mAb development, to clinical and commercial supply – AbbVie can offer extensive global pharmaceutical expertise and a proven partnership option that enhances the value of your external contract manufacturing toward milestone achievement.
Biologics Contract Manufacturing, mAb Capabilities
We offer comprehensive biologics development and manufacturing services from some of the world’s most advanced monoclonal antibody production facilities, applying the most sophisticated equipment, technologies and processes to your project.
- Cell line development (MCB/WCB)
- Upstream/downstream process development, optimization and scale-up
- Stability studies and analytical characterization
- cGMP manufacturing
- Regulatory guidance and support including filing and global marketing approval
- Structured project management
- Process characterization/process validation
Pre-clinical to commercial mAb supply (1kL to 12kL Scales)
AbbVie offers world-class biologics mAb manufacturing in the US and Singapore. Scale options include 1,000L single use bioreactors (SUBs), and 3,000L, 6,000L and 12,000L stainless steel equipment options in various suite configurations. The illustration below offers various examples of our ability to partner with you at any stage of your product development and/or ongoing commercial supply.
Common Biologic Modalities
Cell Culture Manufacturing (Large Molecule)
In biologics manufacturing, success is measured largely by product reproducibility. Through sophisticated cell line development, cell culture manufacturing and quality control processes, we can help you overcome the complexity of large molecule manufacturing to deliver consistent drug performance. Let our excellent track record of biopharmaceutical process development set the foundation for a sustainable, reliable biologics program and ongoing supply of your drug product.
Analytical Services
- HPLC (SEC, IEX, affinity, reverse phase)
- Host cell protein
- Electrophoresis (CE, IEF, SDS-PAGE)
- ELISA
- Peptide structure determination (LC, MS)
- Oligosaccharide analysis
- DNA quantification (threshold)
- DNA identification (PCR)
- Spectrophotometry (FT-IR, UV VIS)
- Bioburden / endotoxin
Client Services
- Stability studies
- Regulatory filing expertise
- Project management and inventory planning
- Scale to accommodate multiple customers simultaneously
- Dedicated time slots for strategic partners
- Exceptional track record of achieving timelines
- History of facility expansion for growing demands
Integrated End-to-End Supply Chain
AbbVie is in a unique position to support your extended supply chain from drug substance to drug product. We also support all elements of antibody drug conjugations (ADCs) within a single quality, operational network as one of the industry’s leading ADC innovators. As a global pharmaceutical company, AbbVie provides extensive expertise and a unified quality and operational network. Our company includes over 30,000 professionals at facilities around the world that can deliver solutions and reliable supply of a wide array of drug components at any phase of development up to and including commercial lifecycle management.
