Boston Institute of Biotechnology (BIB) is an experienced CDMO providing biologics and gene therapy services. BIB would like to share our new CMC technology with you and assist you to reach the next milestone in a timely manner. BIB has provided its partners with success on process development and cGMP manufacturing projects with a shorter turnaround time. Our quality system meets the requirements of FDA, EMA, MHRA, and China NMPA. As a full-spectrum CMC service provider, we offer high-quality non-GMP and GMP services including but not limited to:
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strain and cell line development
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process development and TOX material supply
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process characterization and validation
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cGMP manufacturing (microbial and mammalian bioreactors up to 30,000L capacity), including DS and DP
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gene therapy services: pDNA generation, host cell screening, virus production & purification, GMP manufacturing (BSL2, up to 2,000L), etc.