Episode 61: Why Biologics QC Is So Much Harder Than Small Molecule Pharma | Colette Quinn of Waters

In this episode of  @ChromatographyTalk  David speaks with Colette Quinn, Senior Director within the Biologics Business at Waters Corporation, about the rapidly evolving world of pharmaceutical and biopharma QA/QC.As biologics become more complex, QA/QC labs are being pushed beyond traditional pass/fail testing toward deeper molecular characterization, advanced analytics, and data-driven decision making. Colette explains why “the product is the process” in biologics manufacturing, how chromatography and mass spectrometry are transforming QC workflows, and why orthogonal analytical techniques are becoming increasingly important for understanding critical quality attributes (CQAs).The conversation explores:* Why biologics QC differs fundamentally from small molecule pharma* The growing role of LC, HRMS, MALS, CE, and 2D-LC in QA/QC* Challenges surrounding aggregation, co-elution, heterogeneity, and higher-order structure* How automation, software, and machine learning may reshape future QC labs* The importance of data integrity and standardized workflows* Why advanced techniques like MALS and mass spectrometry are moving downstream into QC environments* How QC teams can think scientifically about adopting new analytical technologiesColette also shares insights on building high-performing analytical teams, the skills needed by the next generation of QC scientists, and where she believes the future of real-time release testing and biologics characterization is headed.Whether you work in chromatography, mass spectrometry, pharmaceutical analysis, biologics development, or analytical chemistry, this episode offers a detailed look at how modern QA/QC is evolving alongside increasingly sophisticated therapeutics.#Chromatography #MassSpec #Biologics #Pharma #Biopharma #QualityControl #QAQC #LCMS #MALS #AnalyticalChemistry #Waters #PharmaceuticalAnalysis #Biotechnology #2DLC #QC #MassSpectrometry