BioLife Solutions starts manufacturing serum-free cell and tissue biopreservation packaging

Published: 24-Jun-2009
Manufacturing Packaging

BioLife Solutions, a US developer of patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs, has completed the construction and validation of its internal GMP manufacturing facility and has released the first production lot of its biopreservation media products. The company said last year that it would move 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 finalised with the input of several cleanroom 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 r&d and quality control laboratories and order fulfilment space. All critical systems are supported by auto-switched generator power.

Mike Rice, BioLife's chairman and ceo, 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 litres of HypoThermosol and CryoStor biopreservation media annually, and have the ability to increase this significantly by investing in additional automation equipment.’ Over the coming months, BioLife expects to realise volume-driven cost reductions and to offer custom packaging and product variants to meet customer demand. www.biolifesolutions.com

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