Process Analytical Technology in Pharma

Gregory K. Webster is an analytical chemist with over 30 years of pharmaceutical industry experience, spanning early-phase drug development through commercial manufacturing for human and animal health products. He holds a BS from St. Xavier College, an MS from Governors State University, and a PhD from Northern Illinois University. He is the editor of several books published by Jenny Stanford Publishing, including Supercritical Fluid Chromatography: Advances and Applications in Pharmaceutical Analysis (2014), Poorly Soluble Drugs: Dissolution and Drug Release (2016), and Chromatographic Method Development (2020).Greg D. Doddridge received his BS in biochemistry from Purdue University and MS in chemistry from Indiana University–Purdue University Indianapolis. He has 23 years’ experience in pharma, including sampling, spectroscopy (NIR, Raman), chemometrics/multivariate data analysis, and analytical method development and validation. Since joining AbbVie in 2018, he has led the small molecule drug product PAT and rapid spectroscopy efforts. Prior to joining AbbVie, he worked at Eli Lilly and Zoetis.Laila Kott is the senior director of Quality Control at Emergent BioSolutions and owner of Skipping Stone Scientific. She earned her BS in chemistry from the University of Toronto, MS in chemistry from the University of Waterloo, and PhD in bioanalytical chemistry from the University of Massachusetts. Dr Kott’s industrial experience spans from early-stage to late-stage to post-approval commitments. She has experience working in several large pharmaceutical companies, contract labs, and biotech startups. Her analytical background reflects her deep knowledge of many analytical techniques, which is echoed in her list of publications, including her previous book with Jenny Stanford Publishing, Chromatographic Method Development (2020).

• 1. From Benchtop to Manufacturing…Gregory K. Webster, Greg D. Doddridge, and Laila Kott2. Sampling the Critical “Before Analysis” DomainRodolfo J. Romañach and Kim H. Esbensen3. Optimizing Good Pharmaceutical Practice through Statistical Process ControlMostafa Essam Eissa4. Chemometrics for PATZhenqi Shi and Benoit Igne5. Continuous Manufacturing of Small Molecule Solid Oral Dosage FormsJohn Wahlich6. Sensors in PATCharu Pandey7. Process NIRPhilip Doherty and Owen Rehrauer8. The Use of Raman Spectroscopy in Pharmaceutical PATBradford B. Behr, Shaun Fraser, and Mark S. Kemper9. Process SpectrophotometryGregory K. Webster10. Online HPLC as a Process Analytical TechnologyJunliang Liu, Yusuke Sato, Paloma Prieto, Vaso Vlachos, and Jason Hein11. Benchtop NMR in Process Analytical TechnologyAnh Le McClain, Blake David Fonda, and Hector Robert12. Process Headspace MonitoringJames Veale13. Process Mass SpectrometryPatrick A. McVey14. Process FBRMWei Li, Wenqing Tian, and Huaiyu Yang15. Terahertz Spectroscopy in Tablet ManufacturingMoritz Anuschek, Jukka Rantanen, and J. Axel Zeitler16. Process Analytical Technology in BioprocessingShailesh Karavadra, Arnaud Di Bitetto, David James, Lin Chen, Juan Villa, Matthew Zustiak, Elizabeth Amoako, David Kuntz, Nimesh Khadka, Lin Zhang, Kevin Broadbelt and Sue Woods17. Method Validation and TransferGreg D. Doddridge18. Regulatory Consideration for PATLaila Kott