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cGMP Production for Drug Substance (DS) Manufacturing

cgmp production
gmp manufacturing boston

cGMP Production for Drug Substance (DS) Manufacturing

cGMP production with high quality and standards

We offer a wide range of cGMP production services to biopharmaceutical companies worldwide with high quality.

Cumulative experiences of mammalian and microbial GMP manufacturing production in compliance with local and global regulatory guidelines. BIB has an international team with highly qualified skills in a broad range of bioprocess experiences.

Offering the following services:

  • Manufacturing in compliance with local/global regulatory guidelines
  • Microbial and Mammalian GMP cell banking
  • Monoclonal antibodies, enzymes, and AAV for gene therapy
  • Protein, Protein remodeling

State-of-the-art facilities

We provide a full spectrum services which utilize next generation technologies, QbD and DoE methodologies. Our experienced scientists deliver the highest quality project results in a timely and efficient manner. We pride ourselves in achieving milestones for our customers with a focused mindset on commercialization.

Gene Therapy, man and bioreactor

Our Capacity

  • Microbial: 50L/200L/500L/2000L/3000L/10,000L/30,000L (supports high cell density
    fermentation with E.coli and P.pastoris)
  • Mammalian: 200L/500L/2,000L/3,000L/10,000L/30,000L
  • Gene Therapy: 200L/500L/2,000L (support and adherent suspension)
    pDNA: 50L/200L/500L
  • Drug product fill & finish (vials/liquid/ lyophilization)
  • IND and BLA writing support (US, EMA, China)
  • Facilities in USA and China
  • 99% client satisfaction
  • 95% projects completed on time

Quality, Compliance, & Expertise

  • Provide follow international CDMO rules taking systematic measures to protect clients IP
  • Provide CMDO services without involvement in drug discovery
  • Support global registration of drugs by providing regulatory expert services
  • Committed to creating a new international CDMO standard (PanFlex©)
  • Technical team has led over 160+ projects to completion
  • Increased drug quality while production price is reduced using our 30000L bioreactor
  • Flexible CDMO partnership model
biotech in boston
Microbial Fermentation

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