Traditionally, when virus clearance studies are performed, staff from the manufacturers DSP department will visit the site where the spiked process runs are conducted. These staff are involved in ensuring that the process steps perform as expected, ensuring comparability to the manufacturing scale. However this can require the manufacturer to have staff at BioReliance typically for 1-2 weeks, leading to an impact on their own internal R&D or manufacturing schedules. The costs for flights and accommodation while at the spiking site also need to be considered. In response to these aspects, BioReliance offers a “Complete Clearance” service, where our highly experienced process scientists will perform all process steps on behalf of the client. These include inactivation, filtration and chromatography studies. We understand the importance of ensuring comparability to the manufacturing scale and we take a number of steps to address this. For instance; technical discussions, review of client SOPs, preparation of customised work books for the lab, technical transfer studies (potentially with BioReliance staff visiting the client’s site) and mock runs to confirm the process has been transferred successfully. We ensure that, in partnership with the client, we identify and measure the critical parameters for the study.
BioReliance has extensive experience in viral inactivation and removal processes, including nanofiltration, column chromatography, pasteurisation, ethanol fractionation, viral in activation by treatment with solvent/detergent and extreme pH, photoactivation, UV treatment, cleaning studies and column re-use studies.
BioReliance has completed validation studies evaluating the use of nanofilters from all the major filter manufacturers. In addition to supporting client activities BioReliance has expertise in running nanofiltration steps using many of the major filter brands on behalf of our clients.
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