BioLife Solutions has announced the completion of construction and validation of its internal GMP manufacturing facility. The company has released first production lot of its biopreservation media products made in Bothell for commercial sales.
The company had announced the transition from using a contract manufacturer to internal production in 2008, in order to reduce production costs and enable custom packaging and formulation offerings for biopreservation media products.
BioLife’s 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 R&D and quality control laboratories and order fulfillment space.
Mike Rice, Chairman and CEO, BioLife, said: 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.