Baltimore, Maryland, USA


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

Would you like to visit our Bayview site?

Request A Tour