Lonza TheraPEAK T-VIVO cell culture medium

Lonza has launched the 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 is designed to improve consistency and process control, simplifying 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 costly and time-consuming manufacturing process. Companies using Lonza’s 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.

The GMP-grade medium is chemically defined and uses only recombinant proteins. By providing good batch-to-batch consistency and supply security, it can accelerate preclinical development, regulatory approval and therapy production. The medium also provides minimal contamination risk and a reduced traceability and documentation burden, the company says.

With supporting documentation available including Certificates of Analysis and a Drug Master File, the T-cell culture medium helps to simplify processes, support regulatory compliance and facilitate scale-up from preclinical development through to manufacturing.