Biocell Therapeutics

BioCell Therapeutics LLC is a specialized consulting firm that offers comprehensive expertise in the field of CMC (Chemistry, Manufacturing, and Controls) drug development, regulatory filing, commercialization, and Product Quality for the biopharmaceutical and cell therapy industries. Our founder and principal consultant, Dr. Nolan Polson, is a seasoned professional with a proven track record in leading successful CMC and Product Quality teams at top-tier pharmaceutical companies such as Amgen, Janssen, Bristol Myers Squibb, Celgene, GSK, and Juno Therapeutics covering multiple modalities such as biologics, small molecules, ADCs, radiopharmaceuticals, and CAR T-cell therapies. Our mission is to provide unparalleled strategic guidance and technical expertise in CMC development and Product Quality, facilitating the successful development, commercialization, and regulatory approval of innovative biopharmaceuticals, cell therapies, and small molecule drugs. Services include: CMC Strategy Development: Crafting comprehensive Chemistry, Manufacturing, and Controls (CMC) strategies tailored to each client's unique drug development, supply chain, control strategy, and commercialization needs. Product Quality Assurance: Implementing robust Product Quality systems, ensuring compliance with regulatory requirements and optimizing quality control and assurance processes. Regulatory Affairs Support: Assisting in the preparation and critical review of regulatory filings, responding to health authorities, and navigating inspections from regulatory agencies worldwide. Technology Transfer and Comparability: Providing expertise in technology transfer, comparability studies, and ensuring seamless transitions from development to commercial manufacturing. Training and Workshops: Conducting specialized training programs and workshops to enhance internal teams' understanding of CMC and Product Quality principles. Contact Nolan Polson at: nolan.polson@biocelltherapeutics.com