Lot Release TestingChris Hebel2019-03-19T12:37:42+00:00
To ensure drug product quality and safety, the FDA requires GMP-level Lot Release Testing for each biopharmaceutical batch produced before it can be released for sale, or export. This testing requires identity, purity, and potency to be completed for all new lots of biologics and it requires comparison with previously established results. Comparability testing ensures that each new batch of product remains identical to the original batch.
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Project Manager, Belgium
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Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences’ services to colleagues and friends.
Senior Scientist, Singapore
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The Avance Biosciences team is committed to strict adherence to cGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
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Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.