All biological products must meet prescribed requirements of safety, purity and potency for regulatory approval. Therefore, data from validated potency testing assays are a critical component of biological licensing applications owing to the complexity and heterogeneity of biologics.
Potency testing involves comparison of a product’s biological activity to that of a reference preparation and cell-based potency assays are central tools used to measure drug efficacy during potency testing. They allow scientists to see how a particular dose of a drug will react in a given biological system.
We can help with performing non-GMP analysis of Biologics and Biosimilar samples from development and manufacturing. We do this by using our iLite Reporter gene cell-based assays to investigate and qualify in order to understand if an assay is fit-for-purpose
Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products; therefore, bioassays are central and critical for product development and manufacturing.
These assays are necessary to ensure the continued quality, safety and efficacy of biopharmaceutical products, and also for the confirmation of biocomparability of innovator and biosimilar product. In turn, these assays must be reliable, standardized, and relevant to reflect the product’s mode of action.
We have extensive experience in establishing, validating, and conducting routine bioassays to GMP standards, and our cell-based iLite® technology combes unique features such as a normalization readout and chimeric transcription factors with a highly flexible product format.
In order to meet the regulatory requirements for the release of biological drugs into the market, biological potency assays are of vital importance for product development and manufacturing processes.
Our biological potency assays are based on the unique iLite® technology and offers key tools to help meet these requirements. Our service offerings include testing of drug substances, final product, intermediates, and starting materials for large molecule drug products. In addition, we have a range of potency assays that can be applied.