Cell Therapy CMC Readiness

Navigating the complexities of Chemistry, Manufacturing, and Controls (CMC) for cell therapy products requires specialized expertise to ensure regulatory compliance and product safety. Our Cell Therapy CMC Readiness consultancy provides comprehensive support to help you prepare for successful product development and regulatory submission.

We offer expert guidance on Mycoplasma Testing for Cell and Gene Therapies (CGTs), ensuring your processes meet the stringent regulatory requirements and maintain the highest standards of product purity. Our services include Regulatory Guidance to help you understand and navigate the evolving regulatory landscape for cell therapies.

Our consultancy also covers the Design of Virus Clearance Studies for AAVs, providing tailored strategies to ensure your CGT products are effectively purified and free of viral contaminants. We conduct General Virus Safety Risk Assessments to identify and address potential viral risks throughout your production process.

Partner with us to enhance your CMC readiness for cell therapy products, streamline your development processes, and achieve regulatory compliance with confidence. Our tailored solutions and expert insights will support you every step of the way.

Dr Andy Bailey

Managing Director & CEO

Andy, originally a chemist/biochemist, later specialized in virology during his 9-year tenure at the MRC Virology Unit in Glasgow, Scotland, where he focused on studying Herpesviruses and Adenoviruses. In 1995, he transitioned to the industry, first as Director of Virus Validation Services at Q-One Biotech Ltd, and later as part of the Pathogen Safety group of Baxter Healthcare in Vienna, Austria.

With over 30 years of expertise in virus and prion safety, Andy has presented at numerous regulatory agencies and conferences, supporting product registrations, and contributing as an invited speaker at expert workshops. His experience includes presentations to regulatory bodies to support submissions for various products, including the UK MHRA, German PEI, French AFFSAPS, US FDA, EMEA, and Japan´s PMDA. This deep involvement has given him a comprehensive understanding of regulatory affairs surrounding virus and prion safety.

Additionally, Andy served as an external expert for the EU SCENIHR committee on emerging human health risks, coauthoring an opinion on “The Safety of Human-derived Products with regard to Variant Creutzfeldt-Jakob Disease”. His ongoing contributions as a speaker at international biopharmaceutical conferences further reinforce his expertise and leadership in the field.

In 2005, Andy founded ViruSure, driven by a commitment to delivering reliable, high-quality testing services to the biopharmaceutical industry, a philosophy that remains a key focal point to the company today. This deep-rooted expertise ensures clients receive trusted, scientifically grounded consultancy, making ViruSure a dependable partner for biopharmaceutical safety needs.