Launching a clinical or infusion site is complex, and the successful management of cell and gene therapy products is crucial for maintaining the integrity and viability of these sensitive materials throughout the cold supply chain.
Consider the following points when maintaining cold chain strategies to ensure critical material is stored appropriately to avoid temperature excursions.
- Value and Impact: Cell and gene therapies often represent cutting-edge medical advancements with the potential to impact patients’ lives significantly. Due to these therapies’ high value and potentially life-changing effects, their proper handling and preservation are paramount to ensure patients receive safe and effective treatments.
- Dependable Cold Storage: Cell and gene therapies often require specific temperature ranges for storage and distribution. Cell therapies typically require cryogenic storage at temperatures as low as -180°C. Dependable cold storage equipment is essential for maintaining the required temperature conditions for storage and throughout the supply chain. Deviations from the specified temperature ranges could lead to loss of efficacy or even the destruction of the therapies, potentially jeopardizing patient health and trial outcomes.
- Temperature Monitoring and Recording: Regulatory agencies, such as the FDA, have stringent requirements for the development, manufacturing, and distribution of cell and gene therapies. Continuous temperature monitoring and accurate record-keeping play a crucial role in regulatory compliance and maintaining the quality and integrity of these therapies. Real-time monitoring systems can provide alerts if temperature excursions occur, allowing for immediate corrective action to prevent any potential damage.
- SOPs and Compliance: Alongside the equipment and infrastructure, well-defined Standard Operating Procedures (SOPs) should be in place to guide every step of the cold supply chain process.
- Collaboration and Training: A collaborative approach involving vendors, infusion sites, key stakeholders, storage partners, and transportation providers is crucial. Clear communication and training among all stakeholders help ensure that everyone understands the importance of maintaining cold-chain requirements.
Cell and gene therapy products hold immense promise for patients, but their delicate nature demands meticulous attention to cold-chain management. By utilizing dependable storage equipment, implementing robust temperature monitoring systems, and adhering to regulatory guidelines, stakeholders can contribute to successfully developing and delivering these therapies while safeguarding patient safety and treatment efficacy.
Contact Pacific Science, LLC, to learn how our team can help select, deliver, validate, and train personnel on various cold storage equipment and provide supplies for your next clinical trial.