Biopreservation In Cell Therapies—Streamlining Compliance With Pre-Clinical Safety Tests

By Maya Rotman and Katy McLaughlin

As cell therapies continue to advance and the demand for these treatments grows, the industry faces ongoing challenges in ensuring that production processes deliver safe products with reproducible performance, scalability, and regulatory compliance. Ensuring product safety, demonstrating efficacy, and navigating complex and dynamic regulatory pathways that may lack harmonization consume valuable time and resources. With growing pressures to provide cost-effective medicines and cell therapies, developers need strategies to build efficient processes with tools and reagents that conform to the relevant standards. Because the cells themselves are commonly the final product, effective cell therapy requires maintaining cell viability, cell recovery, and functionality along the complex supply chain. This relies heavily on the performance of reliable biopreservation solutions for short- and long-term storage and transport.

Access the full application note to learn more.