Size Exclusion Chromatography (SEC) and Polymer Failure Analysis Consultant

Expertise

Summary

Size Exclusion Chromatography (SEC, also known as Gel Permeation Chromatography, GPC) and its application to the compositional and failure analysis of polymers for pharmaceutical, medical device and the chemical Industry. Specific SEC experience includes:

• Molecular mass distribution (MMD) of natural and synthetic polymers, blends and oligomers.
• Analytical method development, validation, transfer, stability studies, quality control, cleanup and release testing procedures.
• Environmental resistance of polymers, including chemical exposure, oxidative resistance, weathering and general method overdeveloped to evaluate polymer environmental resistance.
• Identification and quantification of polymer additives, contaminants and residual monomers.
• High temperature SEC for semi-crystalline, viscous or low soluble polymers.
• SEC separation of small molecules (100-5000Da).
• Enhanced multiple - detector SEC for absolute molecular weight, branching, chain folding, and copolymers analysis (RID with viscosity/ LLS/DAD detectors).
• Preparative SEC for purification, fractionation of the polymers for subsequent analysis by NMR, FT-IR, MS, GC, etc.
• Laboratory techniques, accuracy of calibration method, troubleshooting and data handling.
• Compliance with Code of Federal Regulation (CFR), Guidance for Industry (GFI)

Experience

Independent Consultant, 2009 - Present

• Analytical and physical chemistry support to polymer technologists, engineers and analysts in the plastics, composites and rubber fields.

AP Pharma, Redwood City, CA, Analytical Chemistry Head, 1998 - 2008

• Analytical method development, validation, transfer, stability and release testing procedures for biodegradable products of controlled drug release (microspheres, nanoparticles, implants, semisolids).
• Developed SEC, GFC and other chromatographic separations methods for the whole synthetic route of copolymers containing biodegradable bonds (anhydride, urethane, ortho ester, amide, ester, carbonate).
• SEC/MALLS analysis of PEGylated Protein Modifications (Protein-PEG-Protein bonding, degree of PEGylation, aggregation detection, extent of reaction).
• Worked with Process Development, Technology Development and Compliance to move operations forward in a manner which increasingly assured the company's compliance with the Code of Federal Regulations (CFR), Guidance for Industry (GFI), and site standard operating procedures (SOP) in daily operations.
• Outsourcing interface between AP Pharma and CROs and CMOs.
• Identified, recommended and purchased instruments in support for the analytical services.

National Academy of Sciences, Russia. Laboratory of Biopolymers, Head, 1981 - 1996

• Managed all CMC (Chemistry, Manufacturing, Control) activities for solid oral dosage form tranquilizer "Phenazepam" launched onto European Market.
• Chemistry, technology and pharmaceutical applications of "Melanin" copolymers, and their conjugates with proteins.
• Size Exclusion Chromatography and Gel Permeation Chromatography analysis of natural biopolymers (cellulose, lignin, polysaccharides, proteins, nucleic acids) used in different stages of drug development.
• Provided analytical support to Technology and Product Development departments.
• Liaison between the Russian National Academy of Science and contract laboratories.

Odessa State Academy of Technologies, Professor, Chair of Analytical Chemistry, 1981 - 1996

• Scientific and Program Head for Analytical Chemistry Department.
• Lecturer in Analytical Chemistry, Physical and Colloidal Chemistry, Physical Chemistry of Natural and Synthetic Polymers.
• Responsible for mutual project with Svytoslav Fyodorov Moscow Research Institute of Eye Microsurgery and Carl Zeiss, Germany, devoted to the preparation of silicone and acrylate hydrogels with desirable for IOL contact lenses with controlled hydrophobicity/hydrophilicity ratio.
• Led preparation of hydrogel polymer materials based on co-polymerization of different N-vinyl monomers, hydroxyalkyl methyl acrylates, alkyl methacrylates and polymerizable unsaturated carboxylic acids with a cross-linking agent allyl methacrylate.
• Pioneering work on SEC/Chemiluminescence detection of early polymer failure due to the "local alkalinity" reaction between phenolics and N-containing additives.

PlastPolymer, Saint Petersburg, Polymer Analytical Laboratory Head, 1976 - 1981

• Compositional and Process Failure Analysis with different analytical technologies (SEC, LLS, FT-IR/Raman, DSC, TGA, NMR, MS, ESR, AFM, SERS,XRPD).
• Processing effects (injection molding, extrusion, blow molding, reaction injection molding) on polystyrene, polyvinyl acetate, polybutadiene, polyvinylchloride, polycarbonate, epoxy resin, polypropylene, polyethylene, polyolefins.
• Production control by small molecule SEC (epoxy prepreg analysis, unsaturated polyester, phenolic resins, polymer powder coating, urea/formaldehyde, additives).
• Application of elevated temperature SEC for analysis of ABC, SAN, PET, PEEK, EVA copolymers, acrylics and nylon.

Honors & Publications

Awards

• Russian National Academy of Sciences Award for Service to Chromatography.
• Inventor Society Award for Applied Research.
• Moscow University Distinguished Analytical Scientist Award for Entropic Chromatography.
• Mendeleev Chemical Society Award for Outstanding Analytical Chemistry Paper.
• Ukrainian Technological Academy Award for Outstanding Achievements in Chemistry of Stochastic Copolymers.
• Mechnikov University Technical Achievements Award for laboratory experimentations.

Academic and Professional Affiliations

• Ukrainina Technological Academy (UTA), Acadermician

Publications and Scientific Activities

• 132 publications
• 63 presentations at the local, national and international meetings and symposiums.
• 1 monograph and 1 text-book chapter in biopolymers.
• 35 patents

Education

• D.S. Analytical Chemistry, National Academy of Sciences, Russia
• Ph.D. Polymer Chemistry, Technological University, Saint Petersburg
• B.S. Chemical Engineering (Summa Cum Laude), Polytechnic University, Odessa