Conference: Bioanalytical Control of Biological Drug Substances and Products

Objectives

This new conference track is intended to offer participants the opportunity to find out about modern methods and systems for analysing biological drug substances and drug products and to exchange experiences in this area. A further focus will be on regulatory requirements and developments.

Background

Due to their origin and their extraction from biological systems, biological active substances and medicinal products are subject to a higher risk in terms of purity, identity and residues or impurities than many conventional medicinal products. In the development, authorisation and manufacture of biopharmaceutical products and therapeutics, the verification of purity and identity, e.g. using methods such as HLPC, CE, IEF, MS, etc., therefore plays an important role. This applies to protein-based products as well as cell and gene therapies/ATMPs or modern vaccines. Due to the complexity of the above-mentioned product groups, it is often necessary to consider suitable methods of analysis at an early stage of development, which will also be valid under GMP aspects in later phases.

Target Audience

• Employees and responsible persons who deal with
• Selection of analytical methods
• Validation of laboratory methods
• Design of Experiments (DoE)
• Life Cycle Management

• CROs/CDMOs
• Contract laboratories
• Regulatory and authorisation authorities