Off-site biostorage providers have adjusted to rapid change since the COVID-19 pandemic began. Many processes have adapted to provide additional levels of safety and security for GMP customers and their stored materials. Other aspects of business continuity have been implemented to safeguard against unforeseen events. With these measures, service providers have remained open and available to serve biopharma customers, even with increased demand for GMP storage from biopharma customers. Here are some best practices that top biorepository designers and operators use to ensure safety and mitigate risk.
Safety is critical in biorepository operations. As an industry, we understand the vital role we serve in developing and distributing life-saving biopharma products. Strong safety policies are necessary to protect employees, customers, patients, products and equipment, allowing the global biopharma supply chain to remain functional, both during the pandemic and into the future.
Biorepository employees should be working split shifts, and non-essential workers should be working off-site to reduce COVID-19 transmission. Personal protective equipment (“PPE”) best practices must continue to be taken seriously, as the pandemic is still not entirely under control in the US- let alone globally. All employees must socially distance and wear masks when near others, and enhanced cleaning processes are in place. Also, restrictions should be in place for employees traveling to customer sites and between company locations. Although travel restrictions have relaxed in many parts of the country, we as members of the biopharma and healthcare community have an ethical and moral obligation to continue to take appropriate precautions to stay healthy. Patients depend on us to manufacture, store, transport and administer life-saving treatments now more than ever.
Collaborate Across Departments
Ensuring proper function of biorepository equipment, infrastructure and inventory control systems have always been important. Still, they are now even more critical in a time of rapid change and increased demand for biostorage services. As the types of stored materials change and overall volume continues to increase, storage facilities need to work cross-functionally to accomplish essential maintenance and upgrade objectives. For example, upgrades may need to be performed on existing chambers such as monitoring systems, mechanical systems, and other equipment while new chambers are brought online to meet increased demand for validated GMP storage. During the process, internal departments or outside contractors must effectively coordinate to complete necessary construction, calibration and validation projects ensuring that all equipment, systems and processes are operating in compliance with applicable regulations, guidance and industry best practices to prevent temperature excursions. Inventory control systems should be requalified by validation technicians when substantial changes are made, or a new platform is adopted.
Leverage Redundant Utilities
Dual compressors should be installed on chambers when possible and only the most reliable components should be used. Ultra-low freezers (-60°C ≥-135°C) should ideally have triple redundancies with alternating systems, LN2 backups and multiple generators at each facility to provide continuous power during outages. To further mitigate risk, contract with multiple local fuel delivery companies to ensure a continuous fuel supply to maintain operations in the unlikely event of an extended outage. Facilities and HVAC teams should keep critical chamber parts and supplies on hand to reduce reliance on external contractors and delivery delays. In today’s world of long vendor lead times, be proactive so customers have confidence that their valuable items are safe regardless of what may come.
Cold Chain Transportation
As with chambers, climate-controlled vehicles should be validated if used to transport customer materials between remote locations or to/from customer sites. Proper validation should include seasonal temperature mapping (summer and winter) to confirm that appropriate conditions are maintained inside the cargo area throughout all expected weather conditions. Customers should verify that validated transport is being used, whether provided by the storage facility or a 3rd party shipper.
Across the industry, off-site biostorage providers and companies maintaining their own GMP storage programs have been forced to rapidly change since the COVID-19 pandemic began. Many processes have been adapted to provide additional levels of safety and security for GMP customers and their stored materials. Lessons have been learned- whether it’s developing new PPE processes to ensure employee and customer health or confirming the value of previously implemented risk-mitigation and business continuity programs like forward-looking chamber design, validation and monitoring systems.
As the COVID-19 pandemic wanes, best practices for mitigating safety and business continuity risk will continue to remain important because there will always be new and unexpected challenges to the biopharma supply chain.