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.
Biologics Contract Manufacturing Capabilities
We offer comprehensive biologics development and manufacturing services from some of the world’s most advanced 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 justification/process validation
Cell Culture Manufacturing (Large Molecule)
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.
