Mammalian manufacture of biotherapeutics

Our facility in Hayward, California USA is located 23 miles from the San Francisco Airport.

Acquired by Lonza in October 2017, the site, located in Hayward, CA (USA), has been operating as a multiproduct cGMP facility since 1990. Assets include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities. The site focuses on clinical production of biotherapeutics.

  • 100,00 ft2
  • 17,200 ft2 cGMP facilities
  • 141 people on site, 20/7 operation
  • 90% of workforce is University or Technically certified
  • cGMP operations started in 2000

Manufacturing services available

The Hayward multiproduct facility houses 2 x 1,000L and 2 x 2,000L Thermo Fisher Hyperfoma bioreactors and downstream process capabilities to manufacture product for clinical supply. Focus is on technology transfer of new products into this fully single use facility. Product experience includes a variety of proteins - antibodies, fusion proteins and enzymes.

Upstream capabilities

  • Mammalian Cell Culture Processes (CHO, NS0, Hybridoma, etc.)
  • Seed Train from mL to 50L Cell Bag
  • Inoculum Train Bioreactors Capacity from 50L to 250L
  • Production Bioreactors of 1,000L and 2,000L Single-use Bioreactors
  • Media Preparation up to 2,400L
  • Harvest by Depth Filtration

Downstream capabilities

  • Pre-packed and Lose Resin Chromatographic Columns
  • Viral Inactivation
  • Single Use Ultrafiltration / Diafiltration
  • Buffer Preparation up to 1,200L Batches
  • Bulk Filling in to Bags

Analytical development and testing

  • Raw Material, In-process and Release Testing
  • Microbiological Testing
  • Stability Study Testing

Quality systems and regulatory inspections

We operate global quality management systems and tools which comply with national and international standards and regulation.