BOTHELL, Wash., June 14, 2023 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of class-defining bioproduction tools and services for the cell and gene therapies ("CGT") and broader biopharma markets, today announced that all of its SciSafe-branded biostorage facilities in the USA have been accredited by the College of American Pathologists (CAP).
The CAP Laboratory Accreditation is awarded to laboratories that meet very stringent requirements and maintain the highest standard of quality, accuracy, and consistency, considered equal to or more rigorous than the U.S. federal government's inspection program.
"All SciSafe facilities in the U.S. have earned the prestigious CAP-BAP accreditation, demonstrating our continual commitment to our mission of providing superior quality biostorage services," said Karen Foster, Global Chief Quality Officer at BioLife Solutions.
SciSafe Biostorage Centers of Excellence are now compliant to the following standards:
- ISO 9001
- ISO 20387
- cGMP FDA compliant
- FDA registered and inspected since 2011 (CDER and CBER)
- GDP (Good Distribution Practice)
- CAP-BAP accredited in US facilities as of 2023
Garrie Richardson, SciSafe General Manager commented, "We are proud to receive what is recognized as the highest quality standard to build upon our already impressive list of certifications – offering our clients the best level of protection for their precious biological material."
To learn more about SciSafe's Centers for Excellence and the CAP accreditation, please visit SciSafe.com.
About CAP Accreditation
Pioneered in 2012, the CAP Biorepository Accreditation Program was the first accreditation program designed to improve the quality and consistency of biorepositories. Drawing on best practices from ISBER, NCI, OECD, CMS and the Laboratory Accreditation Program, the goal of the program is to provide requirements for standardization of processes that will result in high-quality human specimens and genetic materials that can be used to support research. Recently, CAP physician members contributed to the ISO technical committee that developed the ISO 20387 standard for biobanking.
About the College of American Pathologists
As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.
About BioLife Solutions
BioLife Solutions is a leading provider of class-defining bioproduction tools and services to the cell and gene therapy (CGT) and broader biopharma markets. Our tools facilitate basic and applied research and the commercialization of new therapies by supplying solutions that maintain the health and function of biologic source material and finished products during manufacturing, storage, and distribution. For more information, please visit www.biolifesolutions.com and follow BioLife on LinkedIn and Twitter.
At the Company
Troy Wichterman
Chief Financial Officer
(425) 402-1400
twichterman@biolifesolutions.com
Investors
LHA Investor Relations
Jody Cain
(310) 691-7100
jcain@lhai.com
SOURCE BioLife Solutions, Inc.
We believe the promise of cell and gene therapies starts with the integrity of a single cell
Advancing the future of cell and gene therapy
The human body can heal itself. Cell and gene therapies are designed to augment the patient’s ability to fight disease but only if the living cells behind those therapies remain viable and functional throughout the production processes. At BioLife Solutions, our mission is to protect the integrity of cells and provide trusted tools, services, and expertise that can enable our customers to advance the development and delivery of cell and gene therapies. We believe the future of cell and gene therapies hinges on the integrity of every single cell and we are here to protect that promise.
We understand the technical demands of bioprocessing in this field, and our advanced biopreservation expertise, cell culture optimization products, innovative storage systems, and closed-system manufacturing solutions are designed to enhance process efficiency, maintain cellular viability, and ensure reproducibility at every stage. Whether scaling up from R&D, navigating clinical trials or optimizing cryopreservation protocols for commercial production, we provide the tools and experience to streamline your workflow and safeguard your therapies.
Streamline workflows and safeguard therapies
GMP-COMPATIBLE
Precision
biopreservation
for
maximum
viability
GMP-COMPATIBLE
Our biopreservation media and storage solutions are engineered to maintain cell integrity and functionality. With GMP-compatible, validated formulations, we help you reduce variability and improve post-thaw recovery, ensuring robust and reproducible outcomes.
CELL VIABILITY
Best
practices
in
cell
processing
CELL VIABILITY
With deep industry experience, regulatory support, and a commitment to innovation, BioLife Solutions is dedicated to supporting bioprocess engineers in overcoming complex manufacturing challenges. Whether optimizing cryopreservation protocols or ensuring the seamless transition from lab to clinic, we are dedicated to your success.
QUALITY & COMPLIANCE
Scalable
manufacturing
and
process
optimization
QUALITY & COMPLIANCE
Enhance efficiency and consistency in your cell processing workflow with our closed-system tools for fluid management and cell processing that are automation ready. Reduce manual handling errors, improve throughput, and achieve higher standards of quality and compliance as you scale towards commercialization.
REGULATORY SUPPORT
Your
partner
in
bioprocess
optimization
REGULATORY SUPPORT
BioLife Solutions delivers specialized tools and expertise to help bioprocess engineers streamline and strengthen biopreservation processes across the cell therapy workflow. From selecting the right biopreservation media to minimizing cell loss during freezing, storage, and transports, our solutions are designed to improve consistency, reduce risk, and support a successful transition from development to clinical application.
Work with experts who understand your biopreservation challenges
Connect with
our
experts
Explore
our
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Collaborative and comprehensive CDMO support
At BioLife Solutions, we partner with leading contract development and manufacturing organizations (CDMOs) to enhance their biopreservation and cell processing capabilities. By providing advanced tools, regulatory support, and process optimization strategies, we empower CDMOs to better serve therapy developers, ensuring quality, consistency, and scalability in cell therapy manufacturing.
Regulatory
readiness
Navigating the complex regulatory landscape of cell and gene therapy requires a proactive approach. BioLife Solutions offers experienced regulatory support to help prepare your biopreservation and cell processing methods to meet global standards. From IND and BLA submissions to compliance with GMP, FDA, and EMA guidelines, our solutions help streamline approval pathways.
STORE
CellSeal®
CryoCase
Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates
Data-driven
decision making
Stay ahead with our comprehensive Evidence Library, a curated collection of scientific publications, white papers, and case studies demonstrating the efficacy of BioLife Solutions’ technologies. Access peer-reviewed research, real-world application data, and expert insights to support your bioprocessing and regulatory strategies.
