BioLife Solutions Announces Validation and Start-Up of new Internal Manufacturing Facility
News Jun 12, 2009
BioLife Solutions, Inc. has announced that it has completed the construction and validation of its internal GMP manufacturing facility and has released the first production lot of its biopreservation media products made in Bothell for commercial sales.
In the third quarter of 2008, the Company announced that it was transitioning from using a contract manufacturer to internal production in order to reduce production costs and enable custom packaging and formulation offerings to the growing market for biopreservation media products.
BioLife’s Quality System and nearly 6,000-square-foot GMP production facility incorporates a uni-directional workflow design that was finalized with the input of several clean room consultants and members of BioLife’s Quality, Scientific, and Regulatory Advisory Board.
The facility consists of ISO14644 classified airlocks and rooms for product formulation, filling, final inspection, and cold storage, as well as other mixed and dedicated use space including research and development and quality control laboratories and order fulfillment space. All critical systems are supported by auto-switched generator power.
Mike Rice, BioLife’s chairman and CEO, noted, “We’re very pleased to have met our cost, schedule, and quality goals for this construction project. We now have the capacity to produce up to 12,000 liters of HypoThermosol and CryoStor biopreservation media annually, and have the ability to increase this significantly by investing in additional automation equipment. Over the coming quarters, we expect to realize volume driven cost reductions and will leverage our internal production capabilities to offer custom packaging and product variants to meet customer demand for our best-in-class biopreservation media products.”