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

Objectives

The conference on bioassays and potency assays, now in its third year in 2026, will focus on both existing and emerging regulatory guidelines. Representatives from regulatory authorities will provide insights into relevant requirements, monographs, as well as their expectations and practical experience. In addition, experts from industry, contract research organisations and CDMOs, as well as scientists from fields such as cell banking, mathematics and statistics, will present their work on the development, validation and routine application of potency assays. The event will cover a range of product classes – from traditional proteins to ATMPs and vaccines – as well as current topics such as the automation of processes and the use of artificial intelligence. The aim of the event is to create a platform for exchange between academia, industry and regulatory authorities to jointly discuss experiences, expectations and perspectives.

Highlights

• Multi Specific Potency and Supporting Methods
• Development Data and Qualification Case Studies for Next-Generation Potency Assays
• MOA-Reflective Assays – Method Design, Use and GMP Validation
• Phase Appropriate Bioassays for ADCs
• Ongoing procedure performance verification (OPPV) for potency methods
• And more

The background to this conference is the steady growth of biopharmaceutical products in clinical development and on the market, particularly in the field of cell and gene therapies (ATMPs). These products are often highly complex, meaning that their bioactivity cannot be determined using conventional analytical methods alone. Additional challenges arise, among other things, from difficult scalability, the handling of very small batches, the quality of starting materials, and limited shelf lives. The development of suitable potency assays is therefore often challenging, especially as multiple testing procedures are usually required for a single product, reference standards are lacking, and the transition from development to the GMP-regulated environment does not always proceed smoothly. At the same time, the determination of bioactivity is an indispensable critical quality attribute (CQA) for release testing. Furthermore, the regulatory framework for these new forms of therapy is still under development, and relevant guidelines and monographs from regulatory authorities and pharmacopoeias have in some cases only recently been published or are still under development.

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

Target Audience

• Representatives of the regulatory and authorisation authorities
• Specialists for biopharmaceutical manufacturing processes
• QA/QC personnel in the biopharmaceutical environment
• Laboratory staff involved in the development and routine use of bioassays/potency assays
• Project managers and outsourcing personnel
• Biologists, analytical chemists and biochemists
• Scientists from academic fields involved in the development of biopharmaceutical products

Moderators

Dr Alexander Knorre, Eurofins

Congress Registration

Early Bird Rebate: Register until 31 August 2026 and save 100 EUR per congress day.

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