Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing.

BioProcess International. (Nov 2015)

Quantitative Risk Assessment of Bioaccumulation Attributable to Extractables and Leachables in Cellular Immunotherapy Biomanufacturing.

Lannon KA, Smith JA, Bure K, Brindley DA.

Abstract

Abstract:

Precious patient samples, contamination concerns, and limited product purification options have compelled manufacturers of cellular immunotherapies (iTx) such as chimeric antigen receptor T cells (CAR-T) and T-cell receptor (TCR) technologies toward the disposables industry. Such companies are implementing single-use technologies (SUTs) almost exclusively. But despite the dominance of disposable bioprocess platforms and their extraordinary growth in the iTx marketplace, researchers have made limited efforts to understand the perennial and critical bioprocessing risks of leachables and extractables.

Here we outline the potential impact on iTx of leachables and extractables and discuss relevant regulations, guidelines, and risk-assessment approaches. Fortunately, biopharmaceutical producers of monoclonal antibodies (MAbs) and recombinant proteins have been investigating the consequences of leachables and extractables on manufacturing processes for years. iTx companies (and the regenerative medicine market in general) can benefit from lessons learned over the past decade of commercial-scale biologics manufacturing in single-use platforms.