Skip to main content
Loading

Managing variability in raw materials and intermediates to ensure consistent product quality

30 Apr 2026
Quality Control
  • How can QC teams detect and quantify raw material and intermediate variability before it impacts critical quality attributes of the final product
  • What analytical controls are most effective for monitoring variability introduced during synthesis, conjugation, and purification
  • How should acceptance criteria for raw materials and intermediates evolve as oligonucleotide and peptide programs move from early development to GMP manufacture
  • What challenges exist in establishing stability indicating methods that are sensitive to upstream variability
  • How can QC functions better integrate with manufacturing and supply teams to prevent variability driven deviations and batch failures

* Agenda subject to change

Chairperson
Vaishali Shukla, Vice President CGT & API Global Expansion - Eli Lilly and Company