Conference: Bioanalytical Control of Biological Drug Substances and Products

25/26 November 2025

Objectives

This newly developed conference track focuses on the analytical control of biological drug substances and drug products, with particular attention to identity, purity, residues/impurities, and related analytical strategies. Techniques such as HPLC, CE, IEF, and MS will be covered, among others.

Background

The number of biopharmaceutical products in development and on the market is continues to grow, driven by innovative therapies including cell and gene therapy, mRNA platforms and phage-based treatments. Many of these products are characterised by their excellent targeting accuracy, but this often comes with a high degree of complexity. Consequently, robust analytical methods are essential to assess the structure, purity, stability, etc. of biopharmaceutical active ingredients and drugs and to investigate any residues, such as host cell proteins.

However, analytical techniques alone are insufficient to fully characterize product functionality and safety. Complementary non-analytical approaches, such as cell-based assays or potency tests, are often necessary to fully evaluate their functionality and safety. The development of biopharmaceuticals is inherently multidisciplinary, requiring collaboration across various scientific and technical domains.

Target Audience

  • The track is aimed at people working in the following areas:
  • Analytical laboratories
  • Development selection and/or validation of analytical methods
  • QC and QA for biological products
  • Approval of biological products
  • CDMO/CRO
  • Representatives of regulatory authorities
  • Supply of systems in the field of analytics

Moderation

Dr Ewoud van Tricht, Kantisto
Prof Dr Cari Sänger - van de Griend, Kantisto

 

Congress Registration

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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

The combined Analytical Identity Testing Strategy for Oligonucleotides
Dr Alexandra Heussner, Vetter Pharma

  • CDMOs needing of ID tests using a simple, fast, highly specific analytical methods
  • A combined ID testing strategy for Oligonucleotides including intact mass determination and a sequence-specific method
  • LC-MS analytics and a sequence-specific UV-determination of the oligonucleotide melting temperature

mRNA Analytics: Last Chance for Platform Methods?
Dr Jan M. Falcke, BioNTech

  • Current state of art (overview)
  • Advantages and limitations of platform approach
  • Platform method case study

Platform Methods - RNA Integrity as Case Study
Susanne Ulrich, BioNTech

  • Design Space
  • Analytical Platform Validation
  • Risk Assessment

A Platform ddPCR Method for the Detection of Residual DNA in mRNA Samples
Dr Christian Schiller, Eurofins

  • Current state of art (overview)
  • Advantages and limitations of platform approach
  • Platform method case study

Capillary Zone Electrophoresis for Oligonucleotide Quality Control – the Power of Gel-free Separations
Dr Jakob Haglöf, Uppsala University, Department of Medicinal Chemistry

  • Capillary zone electrophoresis for oligonucleotide quality control – the power of gel-free separations
  • Oligonucleotides can be analyzed using gel-free capillary zone electrophoresis
  • High resolution separations of same length oligonucleotides based on nucleotide sequence
  • Gel-free separation enables fast and robust separations with quality data

Control of Process-Related Impurities (HCPs) and Regulatory Requirements
Case studies - HCPs as process-related impurities in biopharmaceutical products
Dr Erika Friedl, Paul-Ehrlich Institut, German Federal Institute for Vaccines and Biomedicines

  • HCPs - considered as critical quality attributes
  • Critical HCPs – possible effect on quality and safety
  • Relevance of control for different product classes (e.g. blood products, vaccines, monoclonals, ..)
  • Life cycle control required
  • Characterization by State-of-the-Art Technologies e.g. MS techniques, …
  • Update of regulatory guidance (USP <1132.1>: Residual HCP measurement in biopharmaceuticals by mass spectrometry)

Mass Spectrometry in risk-oriented Host Cell Protein Analysis: The Role and Integration of LC-MS/MS for Qualitative and Quantitative Risk Assessment of HCPs in Biopharmaceuticals
Julia Rauch, Charles River Laboratories

  • Role and expectations of risk-based HCP analysis
  • Mass spectrometry approaches and strategies for risk-based HCP assessment
  • Immunoaffinity enrichment combined with mass spectrometry for HCP coverage analysis
  • Comparative insights from real-world data: What ELISA and LC-MS reveal about HCPs and their associated risks

The Role of Platform Host Cell Protein ELISAs in Biopharmaceutical Quality Control
Dr Florian Semmelmann, Roche

  • The traditional Enzyme-Linked Immunosorbent Assay (ELISA) approach faces challenges, including the long-term management of critical reagents and extensive characterization for product-specific applications
  • A shift toward platform assays, using standardized antibody sets across pipelines, presents an efficient alternative by leveraging similarities in HCP profiles across products
  • This approach enhances process consistency, regulatory alignment, and operational efficiency, addressing key scientific and regulatory considerations in biopharmaceutical development

Wednesday, 26 November 2025

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

Real Time Release Control Strategy for a Biotech Drug Product
Dr Susanne Gawenda, Roche

  • Implementing an RTRT sampling point
  • Using Raman spectroscopy as a multi-attribute method
  • Leveraging the existing rapid microbiology toolbox
  • Current regulatory feedback and the lessons learned

Implementation of a Cartridge-based CE-SDS/cIEF Instrument for Routine Measurement of Drug Product
Johannes Führer, VelaLabs/Tentamus

  • Implementation of the Maurice CE-SDS/cIEF device from BioTechne on site and subsequent qualification of the device in our quality system
  • Establishment of a CE-SDS method for routine analysis of antibody formulation
  • Transfer of a method from a different CE-SDS device to the cartridge-based Maurice device
  • Advantages/Disadvantages of the Maurice device compared to conventional devices

ICH Q5A – Prior Knowledge in Virus Testing and Clearance Studies
Dr Martin Spruth, AGES – Austrian Agency for Health and Food Safety

  • Possible reduction of cell bank testing
  • Virus clearance studies
  • Preconditions
  • Regulatory Expectations

Pragmatic Implementation of ICH Q14: Capillary Electrophoresis for Virus Quantification
Dr Ewoud van Tricht, Kantisto BV

  • Practical, stepwise implementation of ICH Q14 using AQbD tools
  • Full method lifecycle approach: from Analytical Target Profile (ATP) and technology selection to control strategy and lifecycle management
  • Efficient application of Design of Experiments (DoE) to identify and control critical method parameters
  • Capillary electrophoresis (CZE) successfully replaced qPCR for adenovirus quantification
  • All seven process intermediates analysed by CZE within 30 minutes, without sample treatment
  • Virus particle concentration measurable at any production stage within 1 hour (previously 3–4 days)

Development of HPLC-based Methods for Separation and Subsequent Characterization of Morphological Subspecies of a VSV-based Therapeutic Virus
Dr Johannes Solzin, Boehringer Ingelheim

  • Viruses often have different morphological structures (‘subspecies’)
  • It is often unclear whether these have different properties
  • This makes it unclear for process developers, for example, whether certain structures should not be produced at all or whether they should be depleted
  • (Except for AAV, for example) There are no suitable methods available to isolate and specifically characterise subspecies
  • Only such a method allows enrichment of the subspecies and subsequent characterisation and better product understanding

Mastering hcDNA: A Harmonized Approach for AAV Gene Therapies
Dr Denise Teber, Charles River Laboratories

  • Benchmarks current approaches to hcDNA analysis and reporting in rAAV
  • Provides guidance on hcDNA quantification and control strategies
  • Proposes a harmonized approach to normalized reporting of hcDNA
  • Aims to reduce time to market and reduce the risk of delays due to not meeting quality/regulatory expectations
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