Current Challenges for QC and Characterization revolving around the shift toward complex biologics, compressed development timelines, and maintaining data integrity
01 Sept 2026
Quality Control & Characterization
- Monoclonal antibodies, ADC and cell therapies are highly sensitive to environmental conditions, making higher-order structure characterization complicated. How and what methods are being used to address these challenges?
- Expedited regulatory approvals means CMC development often occurs in parallel rather than sequentially, forcing concurrent validation. At what point do companies tend to perform QC analytical qualification and product characterization and if that's been challenged by the authorities and what additional work has been done if challenges were found? (ex. MCB mutation or DNA mutation during development stage)
- Has AI been implemented for QC testing and product characterization and does that post any challenges and how to address it?
- As we shift towards digitalization and automated systems introduce significant cybersecurity and data security vulnerabilities. Has anyone been scrutinized by regulators on laboratory practice and data security and tamper-proof?
Industry Expert
