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.
Key factors Clinical Ops and Researchers should consider when seeking a source for biospecimens
President Obama’s Precision Medicine Initiative (PMI) is gaining traction, and here’s the proof: National Institutes of Health recently awarded $142 million dollars to Mayo Clinic to help establish the world’s largest research-cohort biobank for the Precision Medicine Initiative Cohort Program. Clinical Operations Managers and Researchers in biopharm firms should feel encouraged by the promise of increased access to precision biospecimens.
But what about today? Biopharm can’t wait 5 years to begin to see the fruits of the PMI Cohort Program. Clinical Researchers need a trusted bioservice partner and source of precise biospecimens to fuel their research now.
Here are 4 factors Clinical Operations Managers and Researchers should consider when sourcing precision biospecimens:
1) Exact Regulatory Compliance
A reliable source for biospecimens will uphold all regulatory and other mandates related to the procurement of human biospecimens, such as complying with HIPAA, IRB approval & consent standards.
2) Controlled Sourcing and Storage
Precision Science means being as precise as possible at every stage of discovery. That includes the use of precise samples of blood, tissue, and saliva. Human biospecimens should be treated like gold throughout the entire discovery cycle—from collection and prep to transport and storage. Any fluctuation or variation in a sample will affect the research, and can result in less than optimum results and/or a loss of credibility.
3) Verification of Source Documentation
Poor biospecimen collection practices can bring the reliability of research data into question, which is why it is critical for organizations to have a strong bioservice partner that follows high standards. A reliable source will provide biospecimens of known quality—meaning those that are well characterized, properly consented, sourced and appropriately prepared—and they will be able to provide evidence in advance to support your biospecimen annotation.
4) Proper Data and Specimen Management Systems
Human biospecimens and accompanying data are like money in the bank, and they must be guarded as such. Make sure your biospecimen source offers 21 CFR part 11 compliant Data and Specimen Management Systems with state-of-the-art security, 24/7/365 temperature monitoring, video surveillance and private 24-hour security patrol. Data should also be protected by layered network firewalls, anti-virus gateways and daily backup with redundancy at an off-site secure data center.
Aligning future clinical programs to trusted, reliable resources for precise human biospecimens and solutions enables a more efficient delivery of targeted therapies. That’s the idea behind the Mayo Clinic Precision Medicine Initiative Cohort Program, and one my company, ProMedDx, whole-heartedly supports.
In fact, ProMedDx was founded on this basic idea that quality biospecimens = quality research, and today we are putting pen to paper to see how we can evolve our services to support the PMI. We’ve been collecting biospecimens for nearly two decades, and we are in a unique position to offer a broad representation of blood and tissue from patients with genetic mutations or other alterations that can indicate the likelihood patients will respond to certain medicines and/or specific treatments.
Currently, biospecimens from our repository are being included in the development of several CDx tests that can aid in making better treatment choices for cancer patients. We are passionate about what we do, because we recognize the tremendous potential that Precision Medicine has for improving patient care and reducing healthcare cost.
If you would like more information about our biospecimen collections and support services please contact our Bioservices Team by email or at 800.785.7808.