Our services are performed under GMP and GLP certification to meet regulatory guidance for pre-market and on-market products.

Bioassay, a Reaction Biology Corporation, offers GMP potency assays and functional bioassays, both in vitro and in vivo, as well as GLP-compliant services. Through our sister company PSL, Peptide Synthesis Services, we can also provide peptide-specific antibody production and neoantigen synthesis.

We are a trusted provider of development, validation, and routine bioanalytical assays for global players and biotech companies in the pharmaceutical, chemical, and cosmetic industries. We develop and perform GMP potency assays for a wide variety of drugs and biologics, including proteins, monoclonal antibodies, vaccines, and gene therapies.

Our team of experts works with clients to select the most appropriate assay format and design a robust, QC-friendly, and sensitive method. We follow GMP and ICH guidelines to validate potency assays and offer routine GMP potency QC testing to support upscaling and manufacturing validation processes, as well as batch release and stability testing to monitor product potency over time.