Reduce QC Release Risk with Molecule Specific Analytics: QC Ready MALS in Empower™ CDS
Minimizing QC Release Risk Through Molecule‑Specific Analytics in Empower™ CDS
As MALS gains adoption in QC, many biopharmaceutical labs face a disconnect between absolute molecular measurements and confident lot‑release decisions. Reliance on relative SEC methods, manual calculations, and subjective interpretation can obscure risks related to aggregation, recovery, and molecular distribution - often emerging only during method transfer or regulatory review.
In this webinar, we show how integrating QC‑ready MALS into an Empower™ workflow enables labs to quantify and manage release risk. Standardized calculations convert raw MALS data into objective, reviewable metrics - reducing analyst‑dependent interpretation and supporting defensible release decisions before risks become compliance issues.
What will you learn?
- Transition MALS from characterization to routine QC testing
- Automate critical molecular metrics tied to release specifications
- Improve consistency, traceability, and confidence in release decisions
Who should attend
- QC Managers and Directors responsible for release testing
- MSAT and Method Transfer teams moving methods into QC
- Analytical Development scientists supporting late stage programs
- Regulatory Affairs and Compliance professionals focused on audit readiness
- Organizations working with proteins, peptides, biologics, or complex modalities where aggregation and heterogeneity impact release decisions
Presenter: Colette Quinn, Ph.D. (Light Scattering Portfolio Owner, Waters Corporation)
Colette Quinn is a Sr. business development manager in the biopharmaceutical group at Waters Corporation. Her focus is around biophysical solutions and how to integrate biophysical and biochemical approaches to enable a “totality of evidence” based approach to problems.
Presenter: Neil Lander (Senior Principal Product Manager, Waters Corporation)
Neil has worked for Waters Corporation since 1994 and has held a variety of positions including Technical Support Specialist, Technical Trainer, Manager Customer Education and currently, Senior Principal Product Manager focusing on Informatics solutions.
He provides internal support for Empower Chromatography Data System and is focused on developing laboratory software solutions that help organizations achieve their scientific and operational objectives.
