From Risk to Regulatory Approval: How Cryoport Systems Validated a Shipping Solution, Enabling CGT Commercial Launch

Ensuring safe and compliant product launches for biopharmaceutical success

Launching a new biopharmaceutical product, especially a lifesaving cell therapy, requires meticulous planning and flawless execution, particularly in the realm of temperature-controlled logistics. These therapies depend on precise conditions to maintain their efficacy, making the safe and compliant transport of these products critical.

Cryoport Systems is at the forefront of providing comprehensive consulting services designed to navigate the complexities and mitigate the risks associated with the biopharmaceutical supply chain.

In this case study, you’ll learn how Cryoport’s Consulting Services team addressed critical challenges and provided innovative solutions to support a leading biopharmaceutical company’s commercial launch with a focus on:

  • Tailored Shipping Solution: Developing enhanced shipper designs to meet stringent compliance standards, ensuring products remain within required temperature ranges throughout transit.
  • Rigorous Qualification Processes: Performing thorough thermal and physical qualifications in line with International Safe Transit Association (ISTA) and American Society for Testing and Materials (ASTM) standards.
  • Expert Risk Mitigation: Identifying potential risks and implementing robust solutions to safeguard products, ensuring their integrity and safety during transportation.