http://www.bioprocessintl.com/manufacturing/cell-therapies/the-potential-application-of-real‑time-release-testing-for-the-biomanufacture-of-autologous-cell‑based-immunotherapies/

Onco-immunotherapy is arguably the hottest area in biotech. Juno, Bluebird, AdaptImmune, Novartis to name a few, have all placed significant bets. However, manufacturing scale-up and robust business models for this predominantly autologous – patient specific field – remain significant outstanding issues for the global pharmaceutical industry. As does scalable gene vector production for contract manufacturing organisations (CMOs).

Therefore, IPAV is proud to announce a stellar publication from key members of the IPAV core team and Advisory Board in Bioprocess International.

Autologous immunotherapy manufacturing bioprocesses are inherently more complex in terms of the number of unit operations, the sensitivity of process raw materials to the biomanufacturing environment, and the complexity of available unit operations as compared to MSC manufacturing sequences. For example, a typical iTx work flow may be best considered as two separate work flows: the bioprocessing and manipulation of patient-specific material and the generation of vectors to transduce donor samples, conferring efficacy. Thus, the bioprocessing community is faced with two key iTx process bottlenecks: scale-up and QA/QC. Both of which are core areas of IPAV expertise.

We congratulate the authors and look forward to helping apply their findings to deliver sustained impact to our clients.