Bayview

    Baltimore, Maryland, USA

    Emergent CDMO Sites

    At-a-Glance

    Located in Baltimore, MD (USA), our Bayview facility offers flexible drug substance manufacturing for mammalian, microbial, and viral technologies. Situated on a seven-acre campus, this 112,000-sq. ft. facility comprises four separate manufacturing areas up to 4,000 L scale that employ single-use manufacturing technology with dedicated columns, closed processing, and aseptic processing. The location is certified as BSL2 and EU Grade A-D.

    Development Services and Analytical Capabilities

    The Bayview facility offers a wide range of complex development capabilities for drug substance as well as clinical development and support services, including:

    • Tech transfer support
    • Process optimization, scale-up, and process validation
    • Clinical development to support pilot scale manufacturing
    • Method transfer, method qualification, and/or validation
    • Product in-process, release and stability testing, raw material testing, and assay development
    • Dedicated project management from process development to commercialization

    Manufacturing Capabilities and Technologies

    • Viral manufacturing: vectors, vaccines, live attenuated viral vaccines
    • Microbial fermentation: therapeutic proteins
    • Mammalian cell culture: therapeutic proteins, mAbs

    Clinical-to-commercial cGMP drug substance manufacturing

    • Utilization of single-use bioreactors (SUB) and disposable technologies
    • Flexible, large scale manufacturing capabilities
    • 200L–4000L bioreactors for viral mammalian, avian, insect, and microbial cell cultures
    • Suspension, micro-carrier, and cell-stack based
    • Specializing in protein therapeutics and emerging infectious diseases (EID) vaccines

    Pilot-scale cGMP drug substance manufacturing

    • 1 x 50/75L dual-use SUB
    • 2 Class II Type 2B biosafety cabinets
    • 2 Cell culture incubators
    • Microbial incubator

    Downstream Processing

    • Single-use systems
    • Closed, aseptic processing
    • Depth filtration, chromatography, and ultrafiltration/diafiltration
    • Bulk drug substance formulation

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