How to Choose a Biostorage Service Provider
Clinical trial therapeutics and biospecimens are temperature-sensitive, so transporting and storing them locally and/or globally can be complex. Every day, frozen biospecimens are shipped and received, creating new logistics and storage challenges for even the most experienced supply chain and clinical operations managers.
By identifying a trusted Biostorage Service Provider early in the product development life cycle, Clinical Op’s Managers can ensure proper planning, validation, mitigation and reporting.
Whether that provider is an in-house solution, or outsourced partner, there are specific controls and safety measures that require careful consideration in order to mitigate risk of damage or delay.
Here are the top 4 considerations to include in your biostorage partner search:
Biostorage and Biologistics are increasingly important for maintaining product quality and accommodating the moving timelines of stakeholders such as sponsors, investigators, and researchers. Having a solid plan in place will help eliminate potential biostorage issues that could prevent your biopharma from delivering key discoveries and innovations.
A Biostorage or Biologistics plan should address whether you will accommodate biostorage onsite or outsource, the level of security you plan to provide, and how you will scale up if your inventory or demand suddenly increases.
Onsite vs. Outsourced Biostorage
Carefully consider the Capital Requirements for onsite storage, including the cost of freezers, Dewars, specimen management & temperature monitoring, and back-up power systems. Staffing is also important, as you will need skilled personnel with the proper Certifications & Accreditations, capable of operating with precision within temperature controlled environments.. Lastly, you will need to plan for security, back-up security and 24/7/365 monitoring to protect the biospecimens you are storing. If you can’t confidently manage all of these issues in-house, it’s time to consider outsourcing.
If you choose to outsource, look for a Biostorage Service Provider with experience in cold chain logistics, not just storage. Providers should offer proven strategic expertise in planning, packaging, and transporting temperature sensitive materials.
Certification and expertise is a must. Check to see that a potential Biostorage Service Provider has:
- Documented experience
- IATA Certification
- Specialized personnel
- Documented Quality Assurance System that includes SOP’s for hiring, training, and auditing
- Proven adherence to HIPAA, GCP, GMP, GTPGLP
- 21 CFR Part 11 compliant Inventory Management System
- A Secure Access Web Portal
Make it a priority to choose Biostorage facilities & systems designed to support changing needs. You may not currently foresee an expansion, but it is always a possibility, so you should know how you will accommodate a larger inventory.
Undocumented biospecimen storage practices can lead to a lack of confidence in the reliability of generated data. That’s why it is critically important that Biostorage Service Providers use robust, validated processes and controls. Standards to measure by include:
- cGMP compliant facilities
- Controlled access & reporting of assets
- Environmental controls, such as facility temperature & humidity
- 21 CFR Part 11 compliant monitoring
Mitigating risk with documented controls gives you the assurance that your organization’s biologics are secure in the event of an incident at your facility. Whether you are storing biospecimens onsite or off, they should be properly monitored and protected with:
- A 24/7/365 alarm response
- “at- temperature” redundant storage units
- Back-up power
- Regularly scheduled equipment maintenance
- Calibration in compliance with manufacturer’s specifications
- Inventory tracking from receipt to distribution
- Audit-ready processes
Your organization is responsible for upholding all regulatory mandates related to the procurement of human biospecimens, and should be prepared to address reporting requirements and audits. Be sure your chosen Biostorage Service Provider can give you the proper data access and frequency of reporting to successfully monitor:
- Inventory activity
- Access activity
ProMedDx delivers nearly 20 years of biologistics, biostorage, and biospecimen distribution expertise, providing complete control and transparency to biomaterial control and fulfillment. Our team of experts can assist you in your planning with an end-to-end solution and cGMP compliant workflows that protect biomaterials and research participants while providing the documented source to validate clinical trial data. To learn more, contact us or simply call 800.785.7808.