Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials

In cell and gene therapy, materials matter. However, misconceptions abound, exacerbating a lack of harmonization and standardization in key areas. For example, uncertainty around quality grades at the various stages of R&D is commonplace, and everyday terms are frequently misinterpreted or misunderstood, with potentially damaging ramifications for advanced therapy development, manufacturing and commercialization. Here, we aim to debunk some popular myths, provide practical guidance based upon long experience in the field, and clarify key regulatory considerations and requirements across the cell and gene therapy raw and starting materials area.

Kasey Kime

Senior Manager, Regulatory Affairs Clinical and Compliance Life Science Solutions, Thermo Fisher Scientific Kasey has fifteen years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and regulatory compliance of instruments and consumables developed for automating cell and gene therapy manufacturing. Kasey holds a Bachelor's Degree in Medical Laboratory Science and post graduate degrees in both Microbiology and Quality Systems Management.

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Jerrod Denham ​

Principal, ​Dark Horse Consulting Group​ Jerrod Over the past two decades, Jerrod has led process engineering, development and manufacturing teams within several biotechnology companies developing cell and gene therapy products. At Dark Horse Consulting, he advises biotechnology companies on upstream and downstream process engineering, manufacturing and regulatory through all phases of manufacturing from pre-clinical to commercial. Utilizing his specialized skills in Lean Six Sigma, formalized root cause analysis, statistical data analysis, design of experiments, technology transfer and facility design, he has solved problems relating to CMC of both cell and gene therapy products.

Christopher Bravery

Consulting regulatory scientist, Advbiols Ltd Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

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