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 Company Profile

 

Baxter BioScience Corporation 

1978 West Winton Avenue

Hayward  California  94545  U.S.A.
Phone: n/a Fax: n/a


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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.


 Key Statistics


Email:
Ownership: Public

Web Site: Baxter BioScience Corporation
Employees:
Symbol: BAX
 









 Company News
Repeat Offender: Baxter BioScience Corporation (BAX), the FDA and Too Much Mold to Count 6/12/2013 8:00:33 AM    More...
Marcus Evans, Life Science and Pharma Conferences: Interview With Michael Shires, Vice President for Project and Portfolio Management at Baxter BioScience Corporation (BAX) 2/7/2013 2:41:47 PM    More...
Baxter BioScience Corporation (BAX) Recommends Shareholders Reject “Mini-Tender” Offer by TRC Capital 1/5/2012 6:06:09 AM    More...
Baxter BioScience Corporation (BAX) and Momenta Pharmaceuticals, Inc. (MNTA) Announce Collaboration to Develop and Commercialize Follow-on Biologics 12/22/2011 3:03:20 PM    More...
Baxter BioScience Corporation (BAX)’s Second Quarter Financial Results Exceed Guidance; Company Raises Full-Year Financial Outlook 7/21/2011 8:03:39 AM    More...
Baxter BioScience Corporation (BAX) Receives Positive Opinion for IVIG Therapy in Europe for Treatment of Multifocal Motor Neuropathy 6/24/2011 9:26:38 AM    More...
Baxter BioScience Corporation (BAX) Reports First Quarter 2010 Financial Results In-Line With Guidance 4/22/2010 9:02:29 AM    More...
Baxter BioScience Corporation (BAX) Achieves Record Sales, Earnings and Cash Flow for Full-Year 2009 1/28/2010 8:55:31 AM    More...
Baxter BioScience Corporation (BAX) Appoints Two Corporate Officers 12/15/2009 9:20:35 AM    More...
Baxter BioScience Corporation (BAX) And Halozyme Therapeutics, Inc. (HALO) Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme 7/15/2009 8:42:11 AM    More...
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