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