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Services

We Provide Full Spectrum CMC Services

Microbial Strain and Mammalian Cell Line Development
We can develop a cell line that produces up to 10gm/Liter of monoclonal antibodies.
At BIB, we can provide strain and cell line development services for you. Based on our extensive working experience, we can help you develop different types of mammalian cell lines and microbial strains.
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Microbial strain and mammalian cell line
Upstream, Downstream, Analytical Development
BIB offers technical process development service for the production of recombinant proteins, viral vaccines, and gene therapies using microbial or cell cultures. We focus on developing and deploying reproducible, robust, scalable, and manufacturing-friendly upstream processes and downstream processes.
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Analytical Development for Biologics
  • Analytical method development and optimization
  • Assay qualification and assay transfer
  • Analysis of samples from process development and process characterization studies to track yield and purity
  • Forced degradation studies
  • Elucidation and structure studies
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Learn more about our PC services
  • Next generation PC study that reduces time and cost by 30%-50% when compared to the traditional DoE methods
  • Quality-by-design driven PC studies
  • Pioneer in the field of PC study with 12+ years of hands-on experience in designing and executing PC projects
  • Capability for scale-down modeling to 1L parallel platform for high efficiency
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  • Ultra-large scale commercial production
  • Tox and cGMP production for drug substance and drug product
  • Drug product fill & finish (vials/liquid/lyophilization)
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  • 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
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  • One stop service for pDNA, gene therapy and recombinant AdV/AAV vector production and vaccines from integrated production site
  • Well established multi-expression suspension and adherent production platforms using HEK 293 & SF9 (and microbial fermentation platforms for pDNA production)
  • Efficient and robust AAV purification platform process
  • QbD-driven DoE optimization system to enhance and stabilize AAV vector production
  • Robust and quantitative analytical assays for viral vectors
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  • Blue Whale Program: a PanFlex driven financially risk-free manufacturing solution helping clients reduce construction time and cost by 50%
  • De-risks engineering and technology challenges with our world leading team with established facilities to support the success of products
  • Removes barriers of idle and insufficient capacity
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BIB is a full service CDMO partner offering cGMP and non-GMP mammalian, microbial, gene therapy and cell therapy services.
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