Conference: Bioassays/Potency Assays – Regulatory Requirements, Development and Routine Use

Objectives

The newly developed bioassay/potency assay conference will cover both existing and a number of developing regulatory guidelines and representatives from three different European and US regulatory authorities will talk about relevant guidelines, monographs and their expectations and experiences. In addition, experts from industry, contract research organisations and CDMOs as well as scientists from fields such as cell banking, mathematics/statistics and more will present their work in the development, validation and routine use of potency assays. In addition to various modalities from classical proteins to ATMPs and vaccines, experts will provide insights into the automation of procedures and the use of AI.  The conference is intended to provide a platform for scientists, experts and representatives of authorities to exchange knowledge and opinions and to discuss experiences and expectations.

Background

The number of biopharmaceutical products in the clinic and on the market continues to grow. The focus is increasingly on the area of cell and gene therapeutics or ATMPs. Many of these products are characterised by a high level of complexity. As a result, their bioactivity cannot be measured using conventional analytical tests alone. In addition to the special requirements, e.g. for product and process-related factors such as difficult upscaling, handling and testing of small and very small batches, quality of the starting materials and limited shelf life, the development of suitable potency assays is often a challenge. This includes the fact that one or more assays are usually required for each product, that there are no reference standards and that the leap from development to the GMP-regulated area is not always easy. At the same time, however, bioactivity is an indispensable CQA for release analyses and must be addressed. The MoA is also not always easy to determine, especially with CGT. The FDA also says in its guide: "However, many CGT products have complex (e.g., rely on multiple biological activities) and/or not fully characterized mechanisms of action (MOA), making it difficult to determine which product attributes are most relevant to measuring potency. A further factor is that the regulatory background for these new products is only gradually developing and the authorisation and supervisory authorities and pharmacopoeias have only recently published or still have to draft corresponding guidelines and monographs." A further factor is that the regulatory background for these new products is only gradually developing and the authorisation and supervisory authorities and pharmacopoeias have only recently published or still have to draft corresponding guidelines and monographs.

Articles on Bioassays in our Media Partners' Publications

Read the scientific articles we published with our media partners transkript and BioPharmaAsia on Bioassays. >> Find out more