Modality Solutions and CSafe announced a strategic partnership to provide a next-generation cold chain solution for cell and gene therapies (CGTs). The integrated end-to-end solution will combine Modality Solution’s pioneering capabilities in cold chain engineering with CSafe’s industry-leading shipping solutions to offer unprecedented predictability, quality, and regulatory compliance to the CGT supply chain.
The CGT cold chain, the most complex in the history of medicine, carries unprecedented variability and risk that can compromise the product journey, complicate regulatory filings, and jeopardize patient outcomes. Together, Modality Solutions and CSafe have the solutions, systems, and expertise to reduce risk and bring predictability and consistent reliability to the CGT cold chain, ultimately supporting global scale and patient access for these transformative therapies.
Modality Solutions has supported more than 80 drug approvals in the past three years, with proactive cold chain engineering and validation strategies that have enabled over 300 successful regulatory interactions with more than 45 agencies around the globe. Modality Solutions provides an unrivaled combination of regulatory intelligence, cold chain engineering, and advanced testing capabilities to optimize the cold chain for cell and gene therapies like CAR-T and other regenerative medicines with complex requirements.
CSafe offers the most comprehensive suite of thermal shipping solutions for the global pharmaceutical cold chain, supporting nearly any shipping temperature profile, payload size and duration. CSafe’s rigorously-tested cold chain solutions have earned a 99.99% reliability rating and have supported the temperature-controlled distribution of more than 6.2 billion doses of COVID-19 vaccine worldwide. CSafe also offers next-generation shipment visability through its CSafe Connect digital ecosystem and TracSafe data logger suite.
“We’re very excited to be partnering with Modality Solutions,” said Patrick Schafer, CEO, CSafe. “With the science in cell and gene therapies continuing to excel, the real hurdles remain distribution infrastructure and supporting systems. This partnership is a critical step towards providing a solid foundation that the CGT cold chain can rely on and use as a base for scale and worldwide reach.”
"We partner with world-class companies that are continuously focused on great patient outcomes,” added Gary Hutchinson, President of Modality Solutions. “CSafe has innovative technologies and their focus on the cell and gene therapy supply chain makes them a great fit for us, and more importantly, our clients.”
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