Managing variability in raw materials and intermediates to ensure consistent product quality
03 Sept 2026
CMC & Process Development
- 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
Industry Expert
