Bioassay GmbH is a contract development and testing services organization focused on the development of assays and batch release testing of biologics and drug products under GMP and GLP regulatory guidance. Our team of experienced scientists have more than 20 years of expertise in a variety of analytical techniques and can design and validate potency assays tailored to your specific product and regulatory requirements.
Our services include:
- Assay Development: We can develop potency assays for a variety of drug products and biologics, including proteins, monoclonal antibodies, vaccines, and gene therapies. Our team will work with you to select the most appropriate assay format and design a robust and sensitive method.
- Assay Validation: We follow GMP guidelines to validate potency assays, including establishing accuracy, precision, linearity, and specificity. Our validation process is designed to ensure that the assay is reliable and reproducible, providing confidence in the potency results.
- Release Testing: We offer GMP potency testing for lot release, providing assurance that each batch of your product meets regulatory requirements for potency.
- Stability Studies: We can perform GMP potency assays on stability samples to monitor product potency over time and ensure that the product remains within specification throughout its shelf life.