BioIVT Launches GMP Grade Human AB Serum to Facilitate the Development and Manufacturing of Cell and Gene Therapies

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the launch of its Good Manufacturing Practice (GMP) grade human AB serum, a cell culture supplement to enhance the development and manufacturing of cell and gene therapies.

While there have been advancements in the field of serum-free media for cell and gene therapies, human AB serum has long been the ‘gold standard’ for rapid cell expansion. As the collection and production methods for its manufacture evolve in lockstep with the regulatory requirements of the industry, it will remain a critical component to therapeutic development,” said Trevor Smith, MS, MBA, Product Manager, Immune Cell Portfolio at BioIVT.

Human AB serum supports in vitro cell expansion by providing many of the growth factors, vitamins, nutrients, trace elements and transport factors found in an in vivo environment. By helping to produce biologically relevant conditions, it allows many primary human cells to grow at a faster rate. This is particularly important for autologous therapies that require using a person’s own cells or tissues, which may divide at a slower rate due to chemotherapy.

BioIVT’s GMP-grade human AB serum is produced using the same optimized protocols and enhanced regulatory oversight of source material collection, production, and processing as its research-use only material. But it also has additional viral testing – hepatitis A (plasma-derived only), hepatitis B core antibody, hepatitis E, and parvovirus B19 (plasma-derived only) – and associated documentation.

This product launch follows close on the heels of BioIVT’s acquisition of cell culture sera and blood product manufacturer Valley Biomedical Products & Services and represents an additional investment in the media and reagent space. BioIVT can offer this new product thanks to our extensive blood donor network – we work with 17,000+ donors per year at centers in the US and UK – and Valley Biomedical’s increased capacity, which allows us to generate larger lots with shorter production times,” added Mr. Smith.

BioIVT is offering both plasma-derived and off-the-clot serum collected from healthy, male AB blood type donors. All products are sterile, filtered, and ready for cell culture.

All donor units are tested at the collection facility for viral markers in accordance with current US Food and Drug Administration regulations to ensure they are non-reactive prior to use. Additional testing is also available according to customers’ needs. The final serum product also undergoes extensive quality control testing before release for distribution.

BioIVT experts will be available to answer questions about this new product in booth 644 at Advanced Therapies Week 2022 (formerly Phacilitate), which will be held at the Miami Convention Center, Miami, Florida from January 25-28. A copy of BioIVT’s “GMP Human AB Serum Product Guide” can also be provided by one of their business development managers.

Additional information about this new product line is also available here 

 

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