Workshop: Navigating the Scale Up of Site-Specific Conjugation Processes to Ensure Product Quality & Manufacturing Robustness
Time: 8:00 am
day: Day Two
Details:
As more ADC programs advance towards and through clinical development, scaling up conjugation processes remains one of the most critical steps. This interactive discussion will highlight real-world case studies, pitfalls, and lessons learned in scaling conjugation from lab to GMP production, with a focus on ensuring process robustness and maintaining product quality.
This workshop will cover:
- Case studies in scaling up conjugation: what worked, what didn’t, and the process tweaks that made the difference
- Adapting site-specific conjugation chemistries such as enzymatic, maleimide, and glycan based for GMP and solvent compatibility
- Discussing stainless steel vs. single-use systems for conjugation and purification scale up
- Tackling challenges in purification scale up including peak selection, column packing, and washout curves
