Cell Therapy Quality/ CMC & Analytics

GUEST EDITOR

Guest Editor: Greg Russotti, Vice President, Technical Operations, Celgene Cellular Therapeutics

A perennially challenging area for cell therapy, product characterization/CMC has lately come to the fore as perhaps THE next critical manufacturing-related obstacle that must be properly addressed. Heavily funded consortia and renewed investment (from established tool providers and new faces on the cell therapy scene alike) are helping to drive technological innovation, regulatory guideline development and standardization efforts. But fundamental questions remain: which assays and solutions do you really need to employ? Whose product characterization standards should you meet? And what is the most cost-effective way to strengthen and accelerate Quality Control processes for novel cell therapies approaching commercialization?

  • Recent evolution in product characterization tools (eg. flow cytometry, live cell imaging, single cell analysis)
  • How to reduce the heavy burden of QC and release testing on production timelines and Cost of Goods?
  • How are regulators’ expectations and requirements evolving as cell therapies continue to advance into the commercial sphere – for instance, in regard to potency and comparability?
  • What is the state-of-the-art – and practical utility of – in-process analytics today?