WALTHAM, Mass., February 15, 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.

“There is a large number of cell and gene therapies reaching commercialization in the next few years that will make a significant impact in patients’ lives,” said Chris Armstrong, president, clinical trial services, Thermo Fisher Scientific. “Our integrated services are specifically designed to meet specialized needs for cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labeling and distribution. This will help accelerate the introduction of these important life-saving medicines.”

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 provides 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.

These new services complement the company’s fully integrated development and manufacturing capabilities for cell and gene therapy, which include translational biology, process development and GMP batch manufacturing services to help streamline the path from discovery to clinic across the entire supply chain. This includes cGMP plasmid manufacturing, viral vector services, and cell therapy manufacturing. These end-to-end solutions, combined with an extensive global supply network, supports cell and gene therapy developers across their project lifecycles and help accelerate access to new life-saving therapies for patients.

1. Alliance for Regenerative Medicine. (March 5, 2020). The Alliance for Regenerative Medicine Releases 2019 Annual Report and Sector Year in Review.