Lonza has launched the new TheraPEAK T-VIVO cell culture medium, a novel chemically defined medium developed to optimise CAR T-cell manufacture.
Free from animal-origin components, the medium improves consistency and process control, and simplifies regulatory approval for faster time-to-market.
The manufacture of CAR T cells has traditionally relied on the use of animal or human serum, which is highly variable and may contain adventitious agents. Serum therefore requires stringent safety testing, screening, and stockpiling of suitable-quality batches, making for a more costly and time-consuming manufacturing process.
Companies using the new medium can achieve the required level of performance without needing to add human serum (HS) or components – a problem encountered with many earlier serum-free media. This launch is the latest step in Lonza’s journey to expedite cell therapy commercialication for its customers.
Lonza’s new GMP-grade medium is chemically defined and uses only recombinant proteins. By providing greater batch-to-batch consistency and supply security, it can accelerate pre-clinical development, regulatory approval, and therapy production. The medium also provides minimal contamination risk and a reduced traceability and documentation burden.
Lonza will present a talk with the Fraunhofer Institute for Cell Therapy and Immunology (IZI), which tested the new medium as part of a laboratory-based CAR T-cell manufacturing process, at the American Society of Cell & Gene Therapy (ASGCT) conference. The talk will take place at 15:45 on 18 May 2023, in the Exhibit Hall Presentation Theater at Los Angeles Convention Center.
Erin Brooks, Senior Global Product Manager, Bioscience, Lonza, commented: “Through this launch, we are enabling unprecedented control over raw materials and manufacturing processes, and unlocking greater end-product consistency for customers. With fewer barriers to a faster, more cost-efficient route to market, manufacturers can now focus on what matters: transforming patients’ lives for the better.”
The TheraPEAK T-VIVO medium is available to cell therapy manufacturers globally.