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

25/26 November 2025

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. 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

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

Congress Registration

Programme

Tuesday, 25 November 2025

KEYNOTE on 25 November 2025: Artificial AI in Pharma: The Hype, The Hope, The How
Dr Marcel Franke, Senior Scientist Predictive Formulation, Process Solutions/Upstream & Process Materials R&D Merck Life Science
  • The Hype – Big Budgets, Bigger Promises
  • The Hope – A Shift from Trend to Transformation
  • The How – data Integrity, Human and Organizaional Readiness and Regulatory Enablement

Bioassay Relevant Tests in the Ph. Eur. as well as the Potency Strategy in the Ph. Eur. for mAbs
Dr Solène Le Maux, EDQM

Key Aspects of Assay Control throughout the Analytical Lifecycle
Dr Sonja Klingelhöfer, Richter Biologics

  • Setting of suitable assay and sample acceptance criteria is crucial to control the performance of any bioassay system to distinguish between valid and invalid analyses
  • Due to the complexity of biological assays, many parameters may be relevant, but care should be taken regarding setting too many to get acceptance criteria
  • The precision and accuracy of an assay can be improved by a good replication strategy and performance of statistical outlier testing
  • The capability of the assay should be considered, to control the failure rate and avoid unnecessary repetition based on examples from the praxis, different statistical measures and tests will be evaluated.

Reference Standard Qualifications and Re-Evaluation for Potency Assays
Dr Pieta IJzerman-Boon and Jos Weusten, MSD

  • Concepts of two-tiered reference standard strategies
  • Potency assignment and criteria for qualification and stability
  • Regulatory experience
  • Simulation results

Bioassay Primer: Model-Based Confidence Interval Effects
Dr Florian Müller-Sallanz, Stegmann Systems

  • Impacts of understanding CI implications in bioassay decisions
  • Misunderstandings can affect regulatory approval and scientific rigor
  • Focus on model-based approaches with stable, interpretable CI methods

A (Former) CDER Reviewer’s Perspective on Potency Assays
Gerry Feldman, Formerly FDA

  • A perspective on the current status of potency assays from a regulatory perspective
  • Current developments that will impact potency assay programs now
  • Future aspects

Challenges in Optimization and Validation of Potency Assays in a State Batch Testing Laboratory
Dr Lilija Miller, Paul-Ehrlich Institut, German Federal Institute for Vaccines and Biomedicines

  • Availability of (international) reference material
  • Availability of suitable reagents
  • Sample throughput and the trend to automation

Case Study: Validation and Bridging of a Flow Cytometry Potency Assay for a Therapeutic Monoclonal Antibody
Dr Frances Reichert, Eurofins

  • Validation and instrument bridging data
  • Addressing
    • Challenges
    • Considerations, and
    • Best practices in developing flow cytometry-based assays

Of Mice and (Wo)Men – Development and Validation of a Cell-Based Bioassay for a Commercial Biopharmaceutical
Offering an Ethical and Efficient Alternative to the Conventional In Vivo Mouse Assay
Simone Tomaschek, Roche

  • Measurement of the biological activity by assessing its ability to induce signal transduction pathways in a receptor-expressing cell line
  • Health authorities from FDA and EMA have already approved this regulatory change and implementation is ongoing
  • Learn more about the challenges of switching from animal model to a cell based format

Wednesday, 27 November 2024

KEYNOTE on 26 November 2025: Phage Therapy: History, Current Challenges and Perspectives
Dr Frédérique Vieville, CEO, 5QBD-Biotech
  • From history to today – rediscovering phage therapy in the context of modern medicine
  • Antimicrobial resistance – why phages are part of the answer
  • Challenges: scientific, CMC, regulatory
  • What lies ahead – opportunities and pathways for integration into healthcare

Case Study of an Enhanced Development for a Bioassay
Dr Simon Anderhub, Novartis

  • Explore cutting-edge AI technologies transforming the pharmaceutical industry, with real-world use cases and reference projects from SIEMENS
  • Understand how AI accelerates drug development, from discovery to operations, by enhancing decision-making, speeding up processes, and improving data accuracy
  • Learn about Siemens’ AI-powered tools, including FAIR data frameworks, digital twins, and generative AI copilots that support scientists and engineers across the drug lifecycle
  • Discover how AI democratization enables broader access to innovation, helping pharma companies reduce time-to-market and deliver life-saving medicines more efficiently

'Where Fat and Sugar Meet' – Setup of a Glucose Uptake Assay in Differentiated Adipocytes
Dr Ella Rosenzweig, VelaLabs

  • Set up of a differentiation procedure of 3T3-L1 adipocytes in 96 well plates
  • Development of a glucose uptake potency bioassay in differentiated adipocytes
  • Method fine tuning using Design of experiment (DoE) followed by performance runs using sample mimics
  • Qualification of the assay method

Advancing Bioassay Technologies with NanoBiT Split Luciferase
Dr Jamison Grailer, Promega

  • Novel therapeutic modalities demand innovative bioassay technologies
  • NanoBiT enables sensitive, luminescent potency assays for both established and emerging therapeutic modalities
  • Homogeneous, no-wash formats for quantifying mAb–target, FcγR, and C1q binding
  • Supports mechanism-relevant cell-killing assays for ADCC, ADCP, and ADCs, including bystander activity
  • Delivers rapid, safe, and reproducible assays for potency assessment of viral neutralizing antibodies

Combination of Cell-based Potency Assay with Digital Droplet PCR® Readout as Innovative and New Methodology for Characterization of RNAi Therapeutic Qfitlia®(Fitusiran)
Christine Graf, Sanofi

  • mRNA and RNAi drugs - the complex development of potency assays, which require a sequential setup to combine translational and functional activity while maintaining acceptable variability
  • The combination of a cell-based potency assay with digital droplet PCR® readout
  • Showing acceptable precision and accuracy

Development and Optimization of the Infectious Titer Assay (TCID50) for Recombinant AAV
Annemie Wielant, UCB

  • TCID50 (Tissue Culture Infectious Dose 50) in vitro cell-based assay to measure the infectivity of and its high assay variability, making it sometimesunsuitable for release and stability purposes
  • Evaluation of technical aspects to reduce the variability of the TCID50 assay used on rAAV
  • Following statistical approaches (besides the commonly used Spearman-Kärber method) for data analysis
  • Different options for setting the infectivity threshold value
  • Results of reducing the variability

A Case Study on the Challenges of Establishing a Robust Cell-Based Bioassay for Plasmid DNA Potency Determination
Dr Thomas Danielsen, Novo Nordisk

  • This case study highlights the challenges in developing a bioassay for plasmid DNA (pDNA) API, a non-conventional drug modality
  • Overview of the complexities associated with transient transfection of pDNA in cell-based potency assay
  • Identification and discussion of parameters influencing the dose response curve when cells are transfected with different pDNA concentrations
  • This case highlights the necessity for alternative method development for robustness of bioassays for non-conventional drug modalities

Ensuring Consistency in Bioassay Method Transfer: Strategies for Overcoming Variability
Jessica Weaver, BioAgilytix

  • Phase-appropriate strategies that balance flexibility in early development with the rigor required for late-phase validation to ensure method consistency
  • Recent guidance focus on bioassays and potency assurance strategies, the robustness of these assays and their ability to be moved to multiple locations throughout product development
  • Method transfer
  • Authorities focus on documentation, robust comparability studies, and risk-based approaches to method validation

Making Cell-Based Potency Assays Work Better for QC: A Simpler, Stronger Solution
Peter Wolff, AGC Biologics

  • Insights and real-world case studies on optimizing cell-based potency assays that initially faced challenges in quality control (QC) or suffered from low robustness
  • Targeted optimizations, including changes to detection methods, effector cell lines, and the preparation of assay-ready cell lines
  • Key strategies for assay optimization, troubleshooting approaches, and preferred assay formats, with a focus on QC-friendly detection methods
  • The use of Design of Experiments (DOE) as a powerful tool for identifying optimal assay parameters

Optimizing Cell-Based Assays: A Case Study on Overcoming Development Challenges
Morgane Gesquière, UCB

  • For late phase development, regulatory guidelines require an assay that reflects the intended mechanism of action of the product
  • Developing and validating cell-based assays can be challenging due to their inherent variability; factors such as cell line passage number, culture conditions and other variables can all impact results
  • This presentation addresses the challenges encountered during the development of a cell-based assays through a case study
  • The content includes development strategies, optimization processes (such as selecting suitable suppliers, adjusting incubation parameters, using ready-to-use cells), and approaches for addressing issues like cell detachment and variability. The ultimate goal is to ensure robust and accurate results that meet regulatory expectations.
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