Blog | HemaCare

FDA Policy Changes will Accelerate Cell and Gene Therapy Approvals

Feb 21, 2019 10:02:00 AM / by Nancy Andon, MSc posted in FDA, gene therapy, GMP, cell therapy, gmp-compliant

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The U.S. Food and Drug Administration (FDA) has announced that they are adding staff and rolling out policy changes aimed at advancing the development of safe and effective cell and gene therapies. [1] The announcement came in the form of a press release on January 15th, citing that the new policies are a response to the current surge in cell and gene therapy products that the agency is handling. Based on the number of investigational new drug (IND) applications being submitted, the FDA projects a significant rise in the number of therapies that will be approved over the next few years:

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HemaCare Rings in the New Year with New Headquarters and a Cutting-Edge Collection Center

Feb 5, 2019 10:08:00 AM / by Nancy Andon, MSc posted in GMP, apheresis, cell therapy, cGMP, clinical grade compliance, clinical trial

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HemaCare Corporation’s new global headquarters is officially open for business! The company started 2019 in a brand new 40,000 square foot space in a newly modernized 44-acre corporate campus located in the heart of the San Fernando Valley at Northridge. The design and construction of the cutting-edge facility provide a spacious workspace that promotes the well-being of its occupants, while significantly expanding the company’s on-site capabilities.

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Tregs opens up Exciting Opportunities for Cell Based Therapies

Sep 22, 2014 1:00:40 PM / by Shweta posted in GMP, GVHD, leukapheresis, cell therapy, cGMP, clinical grade compliance, Innovation, research, T lymphocytes, white blood cells, whole blood

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Manufacturing of clinical grade Tregs for cell based therapies

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