Donald Gillies

Primary author and reviewer of CMC sections for various IND, IMPD and BLA filings. Primary responder to CMC questions from Global Regulatory Agencies Develop strategy to assess development of candidate drugs across modalities: glycoprotein enzymes, mAbs, ADCs. New Technology lead. Develop and validate UPLC/HPLC methods (Affinity, RP, SEC, IEX), SoloVPE, enzyme assays, CE-SDS, icIEF, ELISAs. Develop and lead laboratory environmental sustainability initiatives.

Primary author and reviewer of CMC sections for various IND and BLA filings. Primary responder to CMC questions from global Regulatory Agencies (e.g. USA, Canada, UK, Israel, Switzerland, Germany, Japan, Australia) Develop strategy to assess development of candidate glycoprotein drug. New Technology lead. Develop and validate HPLC methods (RP, SEC, IEX), enzyme assays, ELISAs. Manage in-house Analytical Testing Group.

Develop and validate HPLC methods (RP, SEC, IEX). Develop and qualify CE methods for small molecules.

Manage outsourcing of MALDI mass spec-based SNP analysis technology to clients in US, Netherlands, and South Korea.

Developed glycan maps using HPAE-PAD, and 2-AB labelling followed by HPLC-FD, for glycoproteins produced in transgenic rabbit milk.

Purification and characterization of alpha1-3fucosyl transferase enzyme elevated in neuroblastoma.