March 2, 2022 – Cell and gene therapy innovators can now leverage new integrated commercial packaging and distribution services from Thermo Fisher Scientific, designed to seamlessly transition therapies from clinic to commercial launch for patients across the U.S. and Europe.
The Patheon Commercial Packaging Services for Cell and Gene Therapies (CGT) is an end-to-end solution combining the GMP storage, serialization, ultracold and cryogenic packaging, and global distribution that developers need to support their logistics strategies.
The cell and gene therapy market is expected to reach a commercialization inflection point, with the FDA anticipating 10-20 new approvals per year through 2025¹. In launching these new therapies, cell and gene therapy developers require specific validated processes for their commercial logistics strategy from labeling to shipping. Highlights of the new services include:
- Regulatory-compliant serialization: Support for the Drug Supply Chain and Security Act (DSCSA) and Falsified Medicines Directive (FMD) designed to ensure that product identity required for allogeneic products is maintained throughout the supply chain.
- Deep expertise in commercial cold-chain and cryogenic storage and global distribution: In-house shipper fleet enables seamless distribution, with experience shipping to over 5,000 clinical sites worldwide in over 39 countries. This enables critical therapies to get to the right patient, at the right time, at the right temperature.
- Patheon Total Transportation Management: White glove courier services for high value shipments provide complete oversight of supply chain.
- Global infrastructure: Packaging and distribution services available at cryocenters in Frederick, Maryland, and Weil-am-Rhein, Germany, support commercial launches in the U.S. and EU.
- Clinical to commercial scalability: Experienced project teams with expertise in clinical trials designed to enable commercial success.