Anastasiya Manuilov

- Analytical characterization and drug product project representative for Pfizer vaccines (mRNA and protein based), including other drug candidates - Analytical method development and biochemical support for drug substance and drug product materials (from research team supply to clinical drug product at large scale) - Provided analytical support strategies for mid-to-late stage Pharmaceuticals / vaccines - Regulatory document authoring and queries - Collaborate routinely with QC, QA, BIT, Pharm R&D, BRD, Biophysical and Mass Spectrometry, Micro, Vaccine Research and Development and CMC colleagues

- Analytical in-depth characterization of Biotherapeutic protein drug candidates - Development of analytical strategy for novel protein drug conjugates. - Method qualification and tech transfer of protein drug candidates - Routine analytical support of in-process, DS and DP material at different project stages - Authoring CMC sections with primary focus on the elucidation of structure - Technology development committee member

- Served as analytical project lead & representative for protein Pharmaceutical candidates - Routine and In-depth analytical characterization and method development: • Protein Chemistry, Enzyme Kinetics, Peptide Mapping, N-glycans analysis. • RP-HPLC/UPLC, SE-HPLC, CEX/AEX-HPLC and normal phase HPLC (Waters and Agilent). • Protein, DNA, RNA SDS-PAGE, 1D and 2D electrophoresis. • CE-SDS, cIEF, CZE, CE-LIF (Beckman Coulter and Protein Simple/Convergent instruments). • UV-Vis, Fluorescence/CD spectroscopy, Ellman's assay, Bradford assay, Edman degradation, AAA amino acid analysis.

Emphasis on protein analytics and method development.

Studied and worked in the laboratory of Prof. Robert A. Zimmermann. Dept. of Biochemistry and Molecular Biology. Completed Honors Thesis: Analysis of the Peptidyl Transferase Center by Crosslinking [2N3dA76]tRNAPhe-pPuro to E.coli mutant ribosomes. http://www.biochem.umass.edu/faculty-research