Baxter BioScience Corporation
1978 West Winton Avenue
Hayward
California
94545
U.S.A.
Phone:
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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 comprises two main buildings with a combined area of 70,000 sq. The plant is regularly inspected by the FDA, EMEA, TUV, and is ISO 9001 and OHSAS 18001 certified. The two cGMP manufacturing lines comprise bioreactors with capacity sizes of 70L – 400L – 1500L, and 110L – 530L – 2130L. We also have a patented internally oxygenated perfusion technology for cells expressing low titers. Furthermore, the facility has incorporated single-use technology in a variety of areas.
We have incorporated single-use containers from 1L to 600L in size for storage and transport of almost all buffers, media, process intermediates, and purified products. Most recently, we have used Single-Use Bioreactor (SUB) 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 that has traditionally been 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. Our future plans include use of multiple 1000L 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.
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Baxter BioScience Corporation
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Symbol: BAX
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