One of many obstacles highlighted throughout the COVID-19 crisis response was the need for more resiliency in global cold chain infrastructure for storage of temperature-sensitive medications – in this case, mRNA vaccines and COVID-19 test sample specimens. While the pandemic spurred a rapid buildup of worldwide ultracold storage capacity, at an unprecedented scale, it also created a massive new base of first-time cold biostorage technologies stakeholders with the expansion of cell, gene, and biologic drug discovery. With increasing premiums placed on biospecimen integrity, process validation and regulatory requirements, protection of biological assets from stability degradation, biopreservation stresses, and transient warming has become a critical lynchpin for improving success rates in the development and distribution of new therapies with maximum speed and efficacy.
All of this leads to an unprecedented need for expert guidance to solve problems and de-risk the biostorage process for drug discovery testing, development, and production while recognizing gaps for continuous improvement. Utilizing biostorage facilities like SciSafe will help lead the charge for others, with decades of experience supporting bioproduction practices.
What is SciSafe’s Experience?
In recent years, SciSafe has emerged as a thought leader in biological and pharmaceutical storage, entrusted by a high-profile clientele with over 50 million samples at strategically located facilities near Princeton, NJ, Boston, MA, and Amsterdam, Netherlands. SciSafe facilities are certified to ISO 20387 (NJ facilities) and ISO 9001 (US and NL facilities) registered and inspected by the FDA on multiple occasions without any observations. Scisafe has Foreign Manufacturer accreditations with Japan PMDA, and an EU Farmatec registration for Distribution of Active Pharmaceutical Ingredients or API’s.
SciSafe has been further building relationships with leading cell and gene therapy (CGT) developers with biostorage technologies. According to SciSafe’s Founder and President, Garrie Richardson, “Our rigorous attention to execution, validation and regulatory compliance positions us well to support biopreservation best practices and biostorage process excellence.”
Defining Biostorage Process Excellence
Leveraging its biostorage technologies, SciSafe is defining and establishing biostorage benchmarks in response to the demands of its customer base and the rigors of precision bioprocessing. Those benchmarks include:
- Extensive industry experience in establishing cGMP biological and pharmaceutical storage facilities
- Expertise in regulatory compliance, cold chain distribution, storage protocols, equipment management, and sample management
- Continuous improvement of safety systems, data monitoring, and backup contingencies
- Robust Standard Operating Procedures (SOPs) and quality systems, modeled after FDA-required systems for pharmaceutical manufacturers
- Commitment to ongoing investment and development of infrastructure requirements to maintain the safety, integrity, and efficacy of stored biological and pharmaceutical assets 24/7/365
- Mastery of full-spectrum testing and cold storage solutions to continuously protect biospecimens and treatment assets in conditions ranging from +40°C down to -196°C
Big Picture Benefits to Bioproduction
“We understand the need in our space to establish best practices and realize that we are in a unique place to share ours,” stated Richardson. SciSafe plans to further synergies between biopreservation and biostorage, bringing overall improvements to bioproduction workflows that have become increasingly critical to CGT and biopharma communities. Contact SciSafe to learn more about our innovative biostorage solutions.