Bioassay GmbH, a Reaction Biology Company
Bioassay GmbH is a dedicated GxP bioanalytical laboratory specializing in the development, validation, and routine execution of potency and functional bioassays for biologics.
Founded in Heidelberg, Germany in 2002 and part of Reaction Biology since 2022, we are single-site and single-purpose: regulated bioanalysis. GMP certified since 2002. GLP certified since 2008. FDA-inspected since 2012. Veterinary GMP manufacturing license since 2024.
Our services cover GMP potency assays, functional bioassays including ADCC and CDC, immunogenicity testing under GCLP, physico-chemical analysis by HPLC, CE-SDS and SPR, and pharmacopoeial in vivo potency methods. We support programs from proof of concept through validation, registration, and lifetime batch release.
As part of Reaction Biology, our regulated bioanalysis connects to a consultative drug discovery and development CRO with four sites across North America and Europe, giving you one partner from discovery through commercial release.