Peptides are gaining tremendous importance as modern drug substances. Addressing the urge for chemically complex high-quality drugs, cutting edge approaches alongside with well-established work horse technologies are mandatory to cope with rapidly increasing regulatory demands.
Beginning with product-specific understanding and control of e.g., related impurities and aggregation behavior, a broad variety of challenging chromatographic and spectroscopic methods need to be established. In this talk we elaborate on the analytical control strategy and technologies required to achieve highest quality standards and showcase examples from the development of a Glucagon-like-Peptide.
This approach alongside the process development paves the way towards meeting today’s stringent product specifications.

Subject area:
Biologics

Objectives (If applicable):
na

Target Audience (If applicable):
– Regulatory scientists
– Analytical scientists
– Quality assurance analysts
– R&D scientists and managers
– Quality control analysts
– Contract research organizations