Blog | HemaCare

“As the industry and regulatory landscape continues to evolve, it’s vital that as an industry, we take a lifecycle approach to risk management –to ensure that we mitigate as much risk as possible all the way from discovery through to commercialization.” - Dr. Dominic Clarke, Global Head of Cell Therapy, HemaCare

Cell and Gene Therapy Insights has just published HemaCare’s white paper on how to manage starting material quality and stability to maximum effect during cell therapy manufacturing. ^[1] Quality cell therapies can only be created from quality starting materials, yet paradoxically, starting materials are the single greatest source of variability in the cell therapy manufacturing process. Mitigating risk requires minimizing that variability, and also managing shelf-life limitations and biopreservation logistics.

An independent publication in Nature: Scientific Reports cites using fresh leukopaks sourced from HemaCare in their T cell cryopreservation study. The authors, who work at the Cell and Gene Therapy Catapult in London, are studying the impact of cooling and thawing rates on cryopreserved human peripheral blood-derived T cells. In order for the emerging cell and gene therapy industry to effectively ship and store cell-based therapies to global markets, it will be necessary to cryopreserve cell therapy starting materials, as well as the final therapeutic products. To retain peak cellular function, and therefore therapeutic efficacy upon patient administration, it is necessary to understand how to optimize the cryopreservation process.

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 15^th, 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:

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.

It’s getting cold out there! And while winter temperatures may have us yearning for a warm spot by the fireside, cold is a good thing for cell and gene therapies—in many cases, the colder the better. Logistics dictate that international shipping of cellular therapeutics often means freezing them first. Cryopreservation protects fragile cellular material from loss of viability or functionality during transit and storage, by halting chemical and biological degradation processes. To understand how important that is, it is worth noting that two of the hottest cell therapy drugs on the market this year (Yescarta® and Kymriah®) are both cryopreserved prior to infusion into the patient. But how cold does it really need to be to protect the efficacy of these cellular therapeutics? We decided to put that question into perspective.