As pointed out in the Mckinsey & Company article, Port to patient: Improving country cold chains for COVID-19 vaccines, the need for more resiliency in the ultra-cold-chain (UCC) is a significant infrastructure barrier that has hindered the worldwide pandemic response and critical storage of temperature-sensitive COVID-19 vaccines. While this crisis prompted a rapid buildup of global ultra-low temperature (ULT) capacity, it also generated an unprecedented need for…
- The establishment of more rigorous protocols and solutions to protect biological assets from stability degradation, biopreservation stresses and transient warming, as an emerging factor for improving the speed and odds of success in developing and distributing advanced treatments.
- The establishment of best practices and knowledge sources for the new base of first-time ULT storage stakeholders, now supporting the expansion of cell and gene therapy (C>) and biologic drug discovery.
Positioning biostorage facilities like SciSafe as “Centers of Excellence” can help provide expert guidance to solve problems, de-risk the biostorage process and lead the charge for others with decades of experience in supporting bioproduction practices.
How is BioLife Establishing Biostorage Centers of Excellence at SciSafe?
Like Stirling Ultracold who was acquired by BioLife Solutions earlier this year, SciSafe became part of BioLife’s growing portfolio of class-defining bioproduction tools in 2020. SciSafe has emerged in recent years as a thought leader in biological and pharmaceutical storage services and is trusted by high-profile clientele with over 50 million samples at strategically located facilities near Princeton, NJ; Boston, MA; Salt Lake City, UT and a new European facility opening in Amsterdam, Netherlands. SciSafe’s biorepository facilities are certified to ISO20387 and ISO9001, and have also been 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 APIs. They expertly apply multiple cold storage and cold chain technologies, including Stirling Ultracold ULT freezers, to fulfill a wide range of mission-critical biopreservation services for their C> and biopharma customers.
“As we work with platform experts in biopreservation media, controlled rate freezing, cryo and ultra-low freezer storage, SciSafe will leverage the BioLife portfolio with our operational expertise,” noted SciSafe’s General Manager, Garrie Richardson. “We create the perfect platform to build on BioLife’s mission because our rigorous attention to execution, validation and regulatory compliance positions us well to support biopreservation best practices and biostorage process excellence.”
Richardson and the SciSafe operations team have made it their priority to establish biostorage best practice benchmarks in response to the increasing demands of its customer base and the regulatory rigors of precision bioprocessing. Those benchmarks include:
- Extensive experience in regulatory compliance, cGMP facilities, cold chain distribution, storage protocols, equipment management and sample management
- Continuous improvement of SOPs, quality systems, data monitoring and backup contingencies
- Commitment to ongoing investment in infrastructure 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 +70°C down to -196°C
Stirling ULT Technology Completes the Big Picture
With a large portion of SciSafe’s high-value biological inventory stored at temperatures in the -20°C to -80°C temperature range, an in-depth evaluation of ULT storage equipment led them to standardize on the Stirling SU780XLE upright model, even before becoming a part of BioLife. The Stirling team initially worked with the local utility company on SciSafe’s behalf to secure $15,600 in prescriptive energy rebates for replacing inefficient, legacy ULTs with SU780XLE units at their first site installation.
“The high efficiency of the SU780XLE model immediately translated into energy and infrastructure cost savings for our operations, which is very significant when projected over the lifetime of all the freezers,” commented Richardson. “With the advanced technology and onboard connectivity of the Stirlings, they plugged into our existing BMS monitoring platform to give us confidence in their performance and ability to deliver the high sample integrity our customers demand.”
With 320 Stirling units recently installed in their new biostorage facility in Amsterdam, SciSafe understands their unique place in helping establish and share UCC best practices for the global BioLife customer community and industry at large. By establishing SciSafe Centers of Excellence, BioLife plans to further synergies between biopreservation and biostorage, bringing overall improvements to bioproduction workflows that have become increasingly critical to C> and biopharma communities that the company serves.
To learn more about SciSafe and its industry-leading biostorage services, go to www.scisafe.com