Lonza has launched the TheraPEAK® T-VIVO® Cell Culture Medium, a novel chemically defined medium developed to optimize 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 commercialization 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 lab-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.”
Alexis Bossie, Director, Cell Culture Media R&D, Bioscience, Lonza, added: “Lonza is renowned for its cell culture expertise, being one of the first companies to have its cell culture solutions used to manufacture a commercialized cell therapy. We have funneled that know-how into the TheraPEAK® T-VIVO® Medium to meet the pressing market need for a scalable, high-performance medium that sidesteps the challenges of animal components and human serum.”
The TheraPEAK® T-VIVO® Medium is available to cell therapy manufacturers globally. Customers can also access Lonza’s global technical experts for advice and application support to quickly resolve issues and maximize chances of success. With supporting documentation available including Certificates of Analysis and a Drug Master File, this T-cell culture medium simplifies processes, supports regulatory compliance and facilitates scale up from preclinical development through to manufacturing.
