Potency testing

Determine the functional activity of your drug molecule

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

We help you make the most of your bioassay

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. 

Biopharma product testing

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.

Cell-Based Potency Assays

Cell-based potency assays are often the preferred format for potency determination, since they measure the physiological response elicited by the product, which may or may not be extrapolated solely based on demonstration of protein interactions between the product and its intended target. 

Antibody Dependent Cell Cytotoxicity (ADCC) reporter gene assays have also been developed and demonstrated with significantly robust performance. The effector reporter gene cell line can be coupled with an appropriate target cell line to assess the ADCC function of any given product. 

Cell-based Reporter Gene Assays

A reporter gene cell-based assay focuses on the effect of a given treatment on specific cells. These assays can be modified and adapted for applications during the entire drug development cycle as well as for monitoring of biological drugs.

Whether used for the quantification of drug potency or for detection of Neutralizing Antibodies (NAbs), reporter gene cell based assays are an important part of the bioanalytical technology range.

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