Conference: Bioanalytical Control of Biological Drug Substances and Products

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.