Conference: Bioanalytical Control of Biological Drug Substances and Products

Objectives

The number of biopharmaceutical products in development and on the market is growing steadily, driven by innovative therapies such as cell and gene therapy, mRNA platforms and phage-based treatments. Many of these products are characterised by exceptional precision, though this is often accompanied by a high degree of complexity. Consequently, robust analytical methods are essential for evaluating the structure, purity, stability, etc., of biopharmaceutical active substances and medicinal products, and for investigating any residues, such as host cell proteins.

However, analytical techniques alone are not sufficient to fully characterise a product’s functionality and safety. Complementary nonanalytical approaches, such as cell-based assays or efficacy tests, are often necessary to comprehensively assess their functionality and safety. The development of biopharmaceuticals is inherently multidisciplinary and requires collaboration across various scientific and technical fields.

Following its success in 2025, this conference track once again addresses the analytical control of biological active substances and medicinal products, with a focus on identity, purity, residues/impurities and the associated analytical strategies. Techniques such as HPLC, CE, IEF and MS will be covered, amongst others.

Highlights

• ICH Q14 – Using Development Data
• Control strategies and smart statistical approaches in the analytical method performance evaluation for biological drugs
• Strategic Analytical Method Transfer: A Practical Guide to Seamless Transitions between R&D and Quality Control
• Application of a combined analytical ID testing strategy
• And more

Target Audience

• 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