Biopharma product testing
In order to meet the regulatory requirements for the release of biological drugs into the market, biopharma product testing through the use of biological potency assays are of vital importance for product development and manufacturing processes.
Our biological potency assays for biopharma product testing are based on the iLite technology. 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.
Assay precision and Pathway specificity
iLite technology is based upon a reporter gene assay format. Reporter gene cell-based assays focuses on the effect of a given treatment on specific cells. The reporter gene cell lines are engineered by use of target specific reporter gene constructs. Together with cells engineered not to respond to other factors that signal through the specific pathway, a specific and precise assay can be engineered.
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.
A multi-tiered approach is used to measure Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs). The first tiers focuses on detecting and confirming ADAs. In the following tiers, ADAs are characterized with one of these characterizations focusing on the neutralizing activity of the antibody response.
Neutralization Antibody assays
A neutralizing anti-drug antibody response occurs when the ADA inhibits the drug from having an effect on the target of the drug. Through use of the technology iLite, we can offer a full characterization of NAbs. Both the FDA and EMA recommend bioassays for immunogenicity assessment during drug development:
“Generally, the FDA considers that bioassays are more reflective (than competitive ligand-binding assays) of the in vivo situation and are recommended” (Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, Draft issued by FDA, Dec 2009.)
“For most biological products, the most appropriate neutralizing antibody assay is a bioassay which measures the neutralization of the bioactivity” (Guidance on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, issued by EMA, 2012.)
Potency assays for drug release
The traditional approach for assessing the potency of biological products is to develop a quantitative biological assay (bioassay) that measures the activity of the product related to its specific ability to effect a given result.
Due to ethical reasons, it is highly encouraged to use in vitro systems instead of in vivo animal studies. Again, using the technology iLite, there are several available cell lines that can be optimized and validated for new drug candidates. Wieslab also have the capability to work with customer-provided cell lines.