In the dynamic and ever-evolving realm of regenerative medicine and advanced therapies, the reliability of your supply chain could be the difference between success and failure. As the biopharmaceutical industry pushes the boundaries of science and innovation, the need for planning ahead becomes increasingly evident to ensure seamless operations and to uphold compliance with stringent industry standards.
As the leading provider of temperature-controlled supply chain management solutions for the life sciences, Cryoport Systems understands the vital nature that planning ahead plays in delivering your precious therapy without added delays. Let’s take a look at the pivotal role of forward-thinking within supply chain management and how Cryoport Systems’ consistency and planning measures help companies thrive in today’s biopharmaceutical industry.
Mitigating Risk through Proactive Planning
According to the FDA, approximately 70% of drugs proceed from phase 1 studies to phase 2 while only 33% are approved to move on from phase 2 to phase 3. As the difficulty of approval increases from phase 1 to phase 3, the margin of error allotted to risk mitigation drastically decreases. The path from drug discovery to market approval is fraught with uncertainties, from unforeseen regulatory hurdles to unexpected scientific challenges throughout each phase. By meticulously mapping out your supply chain well in advance, companies can identify the potential bottlenecks and vulnerabilities that could arise in the development process. Proactive planning is particularly crucial in ensuring the safe and efficient transportation of cell and gene therapies. If the transportation of these products fails, a patient's life could be at risk.
Cryoport Systems’ expertise in temperature-controlled material transport mitigates the risk that your materials could be subjected to during its shipment journey. To determine your shipment’s route, our team will create a shipping risk assessment that takes an unbiased approach to analyze historical Cryoportal logistics data relative to your specific shipping lanes and selected carriers. This set of metrics, KPIs, and supplemental information acts as a guide for you to select the most effective shipping solutions. Through this forward planning, the risk of potential roadblocks or hurdles is removed from the equation before your material leaves the facility.
Managing Industry Standards through Strategic Planning
A biopharmaceutical company’s operations hinge on its compliance with regulatory guidelines monitored and approved by the FDA or other global regulatory bodies including stringent guidelines for the production, transportation, and storage of cell and gene products. Not meeting or exceeding these guidelines eradicates your company’s credibility and could even result in legal action.
Forward-thinking planning enables companies to implement the necessary infrastructure, training, and quality control measures to meet these standards. Cryoport Systems is registered with the FDA, and our industry experts were paramount in contributing to the development of the standards of ISO 21973:2020 - a guideline that acts to ensure that cell and gene therapies are always transported consistently. Partnering with an experienced service provider like us ensures industry compliance with these standards and gives companies the peace of mind that our practices will always be conducted above board.
Solving Unique Problems Before They Arise
Innovation often brings along unforeseen challenges. The biopharmaceutical industry is no exception. By anticipating and looking for any potential roadblocks and disruptions through proactive planning, companies can allocate resources to research and develop solutions ahead of time. This approach not only minimizes the impact of disruptions to ongoing operations but also showcases adaptability and resilience.
Cryoport Systems' Chain of Compliance® ensures end-to-end traceability for all shipments of sensitive material. The Chain of Compliance® ensures that the integrity of sensitive products is maintained throughout the entire supply chain by providing clients with real-time data on their sensitive materials throughout transit. Having the ability to assess risk and intervene when unexpected problems arise in transit has the power to save time, money, and even lives. By taking advantage of this resource, biopharmaceutical companies can stay ahead of the curve and ensure that potential issues are mitigated.
The biopharmaceutical industry operates at the forefront of scientific advancement. In this high-stakes environment, planning ahead from a supply chain management perspective is both beneficial and imperative. For more information on how Cryoport Systems can add certainty to your supply chain management, check out our clinical and commercial support webpage.