Baxter Bioscience’s Hayward CGMP manufacturing facility offers dedicated capacity backed by 15 years of experience in developing and manufacturing monoclonal antibodies and recombinant proteins. We offer the firepower you need at any stage of development. Our goal is simple: to advance your biologic at any step — from preclinical to commercial — in the most timely and cost-effective manner possible.

This state-of-the-art, licensed facility is located in the premier Biotech Bay for fast and flexible service. Just under 30 miles from San Francisco (in Hayward’s mixed industrialized area), this facility offers global regulatory expertise, intensive yield-improvement programs, mature quality systems, continuous improvement initiatives, and a proven track record for operational excellence.

The one-story facility has two main buildings with a combined area of 70,000 ft². The plant is regularly inspected by the FDA and EMEA, and it is ISO 9001 and OHSAS 18001 certified. Bioreactors on the two CGMP manufacturing lines have capacity sizes of 70-400-1,500 L and 110-530-2,130 L. Furthermore, the facility has incorporated single-use technology in a variety of areas.

We have incorporated single-use containers from 1 L to 600 L in size for storage and transport of almost all buffers, media, process intermediates, and purified products. Most recently, we have used single-use bioreactors (SUBs) for process development and manufacturing of therapeutic proteins for Phase I/II clinical trials for several clients. As a single-use technology, the SUB has greatly reduced the amount of time, space, and expense traditionally required for bioreactor capacity. In addition, because the SUB is a true stirred-tank bioreactor, we have been able to develop, scale-up, and transfer cell culture processes between SUBs and traditional bioreactors. We have successfully developed small-scale processes using traditional screening bioreactors, demonstrated scale-up of those processes using the SUBs in our laboratory, and then transferred the processes to the larger-scale traditional bioreactor suite. We have also successfully completed the installation of multiple 1,000-L SUBs in a GMP manufacturing SUB suite.

To date, we’ve worked with more than 20 monoclonal antibodies and recombinant proteins in various stages of development. We’ve successfully performed numerous technology transfers and received approval for multiple commercial licensing applications in a number of geographic regions.

The comprehensive biologic contract manufacturing services in Baxter include

• vector and cell line development

• cell banking

• cell culture process development

• purification process development

• analytical assay development

• protein characterization

• yield improvement

• pilot, clinical, and commercial-scale CGMP manufacturing

• formulation development

• fill and finish

• quality assurance, quality control, validation, and regulatory support.

At Baxter, we have earned a reputation for operational excellence based on our mature quality systems, global regulatory expertise, intensive yield-improvement programs, and continuous improvement initiatives. We are seeking companies to partner with to bring innovative therapies to life. We know that your ideas can’t make a difference unless they get to the people who need them.