Previously operated by Lonza, this turnkey multiproduct cGMP facility
is purpose-built for clinical-stage biopharmaceutical manufacturing specializing in the production of biotherapeutics, including antibodies, fusion proteins, and enzymes, using mammalian cell culture. The facility supports technology transfer, single-use manufacturing, and comprehensive analytical and regulatory services.
• Upstream Processing: power and utili-ties to operate 2 x 1,000L and 2 x 2,000L single-use bioreactors, enabling flexible, high-yield production.
• Downstream Processing: Robust purification capabilities to ensure product quality and compliance.
• Support Services: Includes pilot labs, analytical testing, stability studies, quality control, and regulatory support for seamless process development.
• Aseptic Filling: Single-use technology for bulk drug substance filling into bags and bottles, with frozen or refrigerated storage options.
• Infrastructure: Designed for 20/7 operations, offering scalability for future teams.
• Location Advantage: Strategically located in Hayward, CA, with proximity to Bay Area Life Sciences hubs
Existing Infrastructure:
• Power (1,000 amps @ 277/480v)
• Backup Generator (1,000 gallons)
• Connectivity for WFI system previously outfitted with 10kL HWFI storage/recir-culation tank and previously installed HWFI loop and POU heat exchangers to ambient WFI.
• New Chiller supporting cold rooms
• 3rd party bulk gas service (O2, CO2 and LN2)
• Upgraded Boilers
• Lift pump for waste to central neutralization system