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Clearance Services

BioReliance has conducted thousands of Clearance studies for clients around the globe.   These studies are required to assess the ability of the manufacturing or cleaning process to produce a product that is safe for use in humans.

Manufacturers of biologics, such as blood products, monoclonal antibodies, recombinant proteins, tissue derived products, and some medical devices, are required to assess the ability of the manufacturing process to produce a product that is safe for use in humans.

The Clearance Services division at BioReliance has performed thousands of Clearance studies.  These have consisted of virus, transmissible spongiform encephalopathy (TSE), mycoplasma, bacterial and DNA clearance studies. Our extensive experience helps us to design the most beneficial and cost-effective studies for our clients. We have performed studies on a wide range of different products and different process steps. Our experience allows us to advise our clients on the most appropriate process steps to study in order to satisfy the regulators.