Chapter 4: Analytical Comparability (chemistry, manufacturing and controls related product attributes)

Doi: 10.4155/FSEB2013.13.133 Author Ashleigh Wake Biotechnology Program Manager Intertek Pharmaceutical Services, Manchester, UK About the Author Ashleigh Wake is the Biotechnology Program Manager at Intertek Pharmaceutical Services, Manchester, UK Ashleigh graduated from Huddersfield University (West Yorkshire, England) with a B,Sc. in Analytical Chemistry and joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. With a background in MS and a career of almost two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, PK studies and API/product characterization, CMC support analytics...