Leading biopreservation tools specialist, BioLife Solutions, Inc., announced today that it has successfully completed audits of its quality systems and GMP production facility in Bothell, Washington. The audit, completed by BSI Group, has resulted in the company’s certification to ISO 13485:2003. The certification is an international standard for quality systems supporting the design, development, and manufacture of medical devices.
In addition to announcing the new certification, the company also stated that its manufacturing facility and quality systems adhere to 21 CFR Part 820 – Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices, 21 CFR Parts 210 and 211 covering GMP for Aseptic Production, Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products, ISO 13408 for aseptic processing of healthcare products, and ISO 14644 for Clean Rooms and Associated Controlled Environments.
BioLife’s chairman and CEO, Mike Rice, commented, “This achievement is a strategic quality milestone for BioLife. Our growing clinical customer base expects us to set a high bar for the production of our GMP biopreservation media products, since many customer applications include the use of our products as a combined preservative/injection delivery solution for cell-based therapies used to treat cancer, heart failure, and a host of other diseases. We’re continuing to enhance the quality footprint of our proprietary, best-in-class HypoThermosol® and CryoStor(TM) biopreservation media products with this certification and updates to our FDA Master Files. Furthermore, we expect to achieve CE Mark conformity for our products in 2010.”
Rice continued, “We also successfully completed quality audits of our new GMP production facility and quality systems by several strategic customers and continue to build our profile as the first choice for clinical grade preservation, transport, freezing, and injection media solutions for cell-based products. We’re pleased that a growing number of clinical customers have selected our products over commercial competitors or internal formulation of preservation media, often made using lower quality components in sub-optimal processes. We’re also very pleased to support our customers with custom packaging and custom formulations of our serum-free, protein-free, pre-formulated biopreservation media products.”