Making Your World-Class Biologics

With patients’ lives at the end of the pipeline, biologics contract manufacturing needs to be safe, reliable and consistent in supply. At AbbVie Contract Manufacturing, we also understand the competitive nature of developing large molecule drugs. Speed-to-market is imperative, along with efficient processes and low costs. Achieving these standards depends largely on the quality of the cell line and the expertise, network and reach of the biologics CMO you choose.

Drawing on our track record of commercializing world-class biologics, we will handle your project with the same level of dedication, meticulousness and innovative thinking as we do our own. We take seriously the trust you place in us as your manufacturing partner and maintain strong, collaborative relationships with our customers throughout the entirety of each project. 

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) 
  • Up-stream/down-stream 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

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.

Drawing on our track record of successfully commercializing some of the world’s most important biologics, we will handle your project with the same dedication, quality systems and expertise from discovery to delivery as we do our own. We carefully safeguard your know-how and value the trust you place in us as your development & manufacturing partner to maintain a strong, collaborative relationship with you throughout the entirety of each project. 

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 one quality and 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 is comprised of over 30,000 professionals at world-wide facilities that can deliver solutions and reliable supply of a wide array of drug components at any phase of development up to and including commercial life-cycle management.