In the first quarter of 2009, we completed the construction and validation of a state of the art cGMP clean room manufacturing suite. In addition to regular production of HypoThermosol, CryoStor, and BloodStor biopreservation media products, we also perform custom formulation, fill, and finish services for direct, distributor, and contract customers.
Custom, Contract cGMP Aseptic Biopreservation
We offer contract biopreservation media manufacturing.
Let us take the hassle out of aseptic, GMP formulation, fill, and finish of your biopreservation media production, so you can focus on your key competencies.
Numerous customers have recognized our quality environment during on-site audits. We’re constantly working to optimize our quality and manufacturing systems and it shows. We get quality!
Our GMP manufacturing facility, located in Bothell, Washington has been qualified according to ISO 14644, Clean Rooms and Associated Controlled Environments as called out in Volume 4, EU GMP Guidelines, Annex 1: Manufacture of Sterile Medicinal Products, with requalification of the facility every six months. The facility was designed based upon the output of risk analysis as per ISO 14971, Application of Risk Management to Medical Devices.
Our Quality Management System is certified to ISO 13485:2003, Quality Management Systems – Requirements for Regulatory Purposes. Regularly scheduled surveillance audits by our certifying authority ensure continued adherence to this standard. Under the standard, we must demonstrate not only the dedication of senior management to GMP standards, but also our commitment to provide quality product using the best available materials and methods.
Contact us if you would like to learn how BioLife can help you with formulation, fill, and finish.