Meeting today’s changing needs: the vital role of biorepositories and archiving facilities in advancing clinical research

In the ever-changing field of clinical research, valid testing and research outcomes are critical, making reliable storage, archiving, and data retrieval an essential component in the research process [1].

Biorepositories and archiving facilities meet this need by providing highly efficient, safe, and secure capabilities for receiving, processing, storing, and distributing biological specimens for clinical trials and scientific innovation.

Easily accessible archiving doesn’t just facilitate solutions for specific challenges, but also provides a basis for connecting broader innovative thought [2].  A well-managed, regulatory-aware repository can tailor support to meet the developing clinical needs of its partners.

Biorepositories must not only match clinical and research requirements, they must also proactively and flexibly adapt to changing needs and anticipate future regulatory developments. It’s vital for storage and archiving services to be able to respond to customer demands with the flexibility, scale, and infrastructure to address dynamic requirements. It’s not difficult to find a striking example of quickly changing needs in the field: the increasing societal, political, and economic impacts of the COVID-19 pandemic have put pressure on governments, with knock-on effects for biopharma, commercially-driven research, the academic world, and collaborative partnerships for research, development, and clinical trials [3]. In the clinical research landscape, priorities can change rapidly – and biorepository support requirements must change with them.

With the healthcare industry facing the unprecedented strain of a pandemic, and a challenging clinical environment in general, it’s more important than ever that all stages in the research process are managed effectively and efficiently. Avantor’s purpose-built storage facilities, proprietary data visibility systems, and transactional capabilities provide the vital supporting tools that valid and effective clinical research needs.

What strengths do state-of-the-art biorepository and archiving facility providers bring to clinical trials?

As a well-established resource for clinical research, forward-thinking biorepository and archiving providers must be continually innovating to provide better solutions and improved technologies.

That requires supplementing accepted fundamentals with innovation to create sustainable and effective approaches, including:

• Flexible storage: Stable and compliant storage at ultra-low temperatures transcending previous limits is necessary to assure the required standards for new testing and research [4], a field in which Avantor provides market leading support such as LN2 vapor phase storage capabilities to provide high levels of security against contamination [5].
• Scalable capacity: Storage capacity must be sufficient for today’s requirements, but also scalable to meet increasing demand in the future, all within a consciously sustainable framework [6].
• Adaptable archiving and retrieval: Techniques must be capable of meeting previously unconsidered storage challenges. These are a necessity for effective research and clinical test-friendly sample storage, as facilities must be flexible enough to meet customer demands (for example, widely varying temperature needs, from controlled room to cyrogenic storage).
• Infrastructure: These strengths must be backed by a reliable infrastructure – a requirement for storage, delivery, and customer support – that meets compliance needs with safeguarding such as back-up systems and redundancies to ensure the security of critical research assets.
• Management systems: Infrastructure can be further enhanced with powerful material management systems [7] that provide 24-hour, multi-site visibility along with full tracking and traceability.
• Strategic locations: Another vital necessity for a rapid response to global demands, central locations provide researchers with the ability to easily access storage in multiple areas in environments that minimize risk while enabling the rapid retrieval of assets.
• Innovative client-facing teams: To help ensure best practice for pharma and biotech-led research, biorepository and archiving facilities must be managed by flexible, customer-focused teams able to find swift, practical solutions for problems that would once have seemed insurmountable [8].

At Avantor, these strengths are backed by our purpose built, state-of-the-art facilities with a well-established, globally consistent record of multi-site archived sample visibility, asset safety, and efficient and consistently visible sample tracking. Standard operating procedures and quality compliance are consistent across our sites, giving our customers confidence that their samples and research assets are getting the care and regulatory compliance their research requires [9].

These factors provide the basis for valuable business continuity planning and multiple examples of demonstrably successful partnerships with our customers.

Supporting research challenges

Avantor is a trusted partner to a widely diverse and expanding customer base. Our customized services and core competencies provide rapid solutions for our clients’ scientific challenges.

Finding vaccines, for example, involves not just following promising leads but also innovation and collaboration throughout the entire clinical study [10]. Here, reliable biostorage and archiving that meets regulatory requirements is a prerequisite for monitoring progress – and validating the effectiveness of vaccines and treatments desperately needed around the world.

Avantor’s biorepositories supply essential support in this research, such as:

• Scalable biorepository facilities and archiving that help facilitate clinical trials.
• Safe and secure storage and distribution for materials, including biological samples and research data.
• Regulation-compliant storage and logistics with comprehensive and transparent chain-of-custody procedures.
• Tailored solutions and a proactive client-centric approach to manage unforeseen hurdles and unique challenges.
• Reduced cost, risk, and complexity for clinical trial managers.

Research and clinical testing organizations know they can rely on our capacity, flexibility and expertise for support across a wide range of logistical sample storage, delivery, and retrieval needs – and we join the healthcare industry in rising to meet the new challenges posed by an ever-changing clinical landscape.

Moving into the future

The vital needs of today’s ongoing research require partners committed to maintaining state-of-the-art biorepository and archiving services through multi-site archiving and high levels of data visibility, with tracking linked to active sample management, as well as real-time proprietary material management systems and solutions-focused teams.

Biorepository and archiving experts are currently providing vital support to multiple research trials, but the future requires continuing advances that will help research meet new challenges. At Avantor, we answer this challenge by providing flexible, scalable storage and archiving capabilities – backed by an outstanding record of asset safety and state-of-the-art, strategically located facilities – enabling us to reliably meet current and future demand.

This article has been produced by Avantor Clinical Services as part of our ongoing commitment to setting science in motion to create a better world through the delivery of mission-critical products and services. To learn more, contact us today.

Learn more about our Biorepository and Archiving capabilities

References

1. Jimmie B. Vaught, Marianne K. Henderson, and Carolyn C. Compton. Biospecimens and Biorepositories: From Afterthought to Science. Feb 2012. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3277207/. Accessed July 2020.
2. Jerome Premmereur. COVID-19: vaccine innovation and safety at pandemic speed. July 2020. https://blog.covance.com/2020/06/covid-19-vaccine-innovation-and-safety-at-pandemic-speed/. Accessed July 2020.
3. Dale Smith. How long until a coronavirus vaccine is ready? Here's the latest information. June 2020. https://www.cnet.com/how-to/how-long-until-a-coronavirus-vaccine-is-ready-heres-the-latest-information/. Accessed June 2020.
4. DAIDS Guidelines for Good Clinical Laboratory Practice Standards. Effective from September 2019. https://www.niaid.nih.gov/sites/default/files/gclp.pdf. Accessed August 2020.;  Guidelines for Human Biospecimen Storage, Tracking, Sharing, and Disposal within the NIH Intramural Research Program. September 2019. https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-biospecimen.pdf. Accessed August 2020.; Elizabeth Tilley Hinkle. Develop Investigational Drug Management Standards to Withstand Regulatory Scrutiny. May 2020. https://www.centerwatch.com/articles/24689-develop-investigational-drug-management-standards-to-withstand-regulatory-scrutiny. Accessed August 2020.
5. -196 degree symbol C LN2 vapour phase tanks. https://www.eplarchives.com/about/biostorage-facilities/. Accessed August 2020.
6. Sustainability. https://www.avantorsciences.com/pages/en/sustainability. Accessed July 2020.
7. Equipment & Instrument Services. https://uk.vwr.com/cms/avantor_services_equipment_instrument_services. Accessed July 2020.
8. Avantor Clinical Services supports the need to fast-track clinical trials related to COVID-19 disease progression. https://www.avantorsciences.com/pages/en/success-story-coronavirus-detection. Accessed July 2020.
9. Quality and compliance. https://www.avantorsciences.com/pages/en/quality-compliance. Accessed July 2020.
10. Collaboration Speeds COVID-19 Research. https://ncats.nih.gov/covid19-translational-approach/collaboration. Accessed July 2020.; Innovation to Respond to COVID-19. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/innovation-respond-covid-19. Accessed July 2020.