Expert Details

Expert in Biodegradable Systems for Controlled-Release Drug Delivery

Expert ID: 727211 California, USA

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Expert has a D.Sc. in bioorganic chemistry, a Ph.D. in polymer chemistry and over 25 years of experience in analytical and physical chemistry of biopolymers. In a very recent assignment Expert has established and directed an analytical chemistry department with main focus on three types of biodegradable drug delivery systems (matrix based systems, stimuli responsive systems, and polymer-drug conjugate systems) containing different biodegradable bonds: ester, ortho ester, amide, anhydride, carbonate, urethane.

Expert provides consulting for technical areas of product development, analytical R&D and Quality Control laboratories. Expert offers a number of solutions specifically aimed at desired delivery route, either based on generally available formulation strategies or through proprietary, patent-protected technologies. Expert also serves as outsourcing interface between internal admin and CROs and CMOs

Subject matter expert in analytical and physical chemistries of biodegradable drug delivery vehicles, strategies of their usage in case of vaccine, protein, and small molecule APIs for different routes of controlled delivery. Expert can help comprehensively characterize biodegradable Drug Products for the chemistry manufacturing and controls (CMC) part of regulatory submissions for the approval of clinical trials, and the authorization to market a new product.

Expertise includes:
• PHYSICO-CHEMICAL CHARACTERIZATION OF BIODEGRADABLE POLYMER AND DEVICE (synthesis and structural characterization; molecular masses (Mw, Mn, Mw/Mn); polymer end-groups; surface tension; hydrolysis pathway and reaction rate kinetics;pK; partition coefficients; unreacted monomers; residual solvents; degradation products; diffusion coefficient of water and other molecules; hydrophilic-lipophilic balance, HLB; physical form of vehicle- semisolid, microspheres, nanoparticles, coatings, strands)
• EXCIPIENT COMPATIBILITY (pros and cons to use different excipients, including MPEG, PEG, Poloxamer; polymer solubility parameters; plasticization effect; matrix homogeneity; uniformity of drug distribution)
• FORMULATION STABILITY IMPROVEMENT based on deep understanding of the underlying mechanisms of drug instability and degradation, including physical and chemical pathways as well as internal and external factors affecting drug stability within the delivery matrix (matrix-drug interactions, internal environment, site of delivery).
• ANALYTICAL METHOD DEVELOPMENT, VALIDATION, TRANSFER, STABILITY STUDIES AND RELEASE TESTING PROCEDURES FOR DRUG SUBSTANCES AND DRUG PRODUCT USING MODERN ANALYTICAL TECHNOLOGIES (HPLC; IEC; IEF; low and general range GPC/SEC; MALLS; FT-IR/NIR/Raman; NMR; LC-MS; GC-MS; dynamic viscosity; TGA; DSC; KF; dynamic LLS)
• IN VITRO RELEASE (IVR): modeling and simulation to predict and correlate matrix degradation, drug release kinetics and release parameters.
• TECHNOLOGY OPTIMIZATION (flexible delivery times of controlled release, the improvement of the bioavailability of low soluble drugs, the delivery of two or more drugs from the same formulation, the possibility of having clearable polymer carriers, the improvement of the targeting to tissues or cells, proper manufacturing techniques).
• COMPLIANCE. Expert success is based on the fact that he offers the highest quality and best value consulting available while meeting the necessary regulatory requirements with Code of Federal Regulation (CFR), Guidance for Industry (GFI), CDER, CBER, FDA, EMEA, ICH.

Consulting for technical areas of biodegradable polymer technology and product development, analytical R&D and QC labs.Audit or gap analysis of analytical development/validation and QC labs for technical integrity and cGMP complianceConsulting in Modeling and Simulation of "matrix-drug" interactions to predict and correlate IVR matrix degradation,
kinetics and drug release parametersSelection, coordination and management all contract analytical, formulation, manufacturing activities with multiple external CROs/CMOs.Consulting for Pharmaceutical and Medical Device Quality Assurance

Expert may consult nationally and internationally, and is also local to the following cities: San Jose, California - San Francisco, California - Sacramento, California - Oakland, California - Stockton, California - Fremont, California - Modesto, California - Salinas, California - Santa Rosa, California - Hayward, California

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Education

Year Degree Subject Institution
Year: 1985 Degree: D.Sc. Subject: Bioorganic Chemistry Institution: National Academy of Sciences, Ukraine
Year: 1972 Degree: Ph.D. Subject: Polymer Chemistry Institution: Saint Petersburg Technological University
Year: 1968 Degree: BS Subject: Chemical Engineering Institution: Odessa State Polytechnical University

Work History

Years Employer Title Department Responsibilities
Years: 1998 to 2008 Employer: AP Pharma Title: Associate Director, Analytical Chemistry Department: Responsibilities: Analytical Chemistry and CMC of Biodegradable Drug Delivery Systems for Controlled Drug Release
Years: 1996 to 1997 Employer: Athena Neurosciences Title: CMC Consultant Department: Responsibilities: Proteins, small molecules formulation and delivery
Years: 1981 to 1996 Employer: Physico-Chemical Institute of the National Academy of Sciences Title: Head of the Biopolymers Department Department: Responsibilities: Chemistry, technology, pharmaceutical applications of MELANIN copolymers, and their conjugates with proteins.
CMC of oral dosage forms formulations.
Years: 1981 to 1996 Employer: Odessa State Academy of Food Technologies Title: Professor, Chair of Analytical Chemistry Department: Responsibilities: Scientific and Program Head for Analytical Chemistry Department. Lecturer in Analytical Chemistry, Physical Chemistry, Chemistry of Natural Polymers.
Years: 1973 to 1978 Employer: Plastpolymer, Saint Petersburg Title: Head of Block-co-polymers Lab Department: Responsibilities: Subject matter expert in new methods of synthesis of biodegradable co-polymers and their usage in Pharmaceutical and Medical Device industries.

International Experience

Years Country / Region Summary
Years: 1990 to 1992 Country / Region: Russian, Germany Summary: Implemented new synthetic strategy for “living block-co-polymerization” and its use for the preparation of silicone and acrylate hydrogels with desirable for IOL/CONTACT LENSES hydrophobicity/hydrophilicity ratio (mutual project with Svyatoslav Fyodorov Moscow Research Institute of Eye Microsurgery, and Carl Zeiss,Germany )
Years: 1986 to 1987 Country / Region: Russia Summary: Pioneering work on chemistry and technology of MELANIN pigments – a new type of “switched” antioxidant copolymer possessing powerful antistress and radio-protective activities. Proprietary formulation under the trade name “ENOMELANIN” was used in Ukrainian clinics during accident on Chernobyl atomic power station.
Years: 1981 to 1983 Country / Region: Russia Summary: Expert managed all CMC activities for launching first Russian solid oral dosage form tranquilizer PHENAZEPAM onto European Market

Career Accomplishments

Associations / Societies
Controlled Release Society (CRS), American Chemical Society(ACS)
Licenses / Certifications
Academician of Ukrainian Technological Academy
Awards / Recognition
National Academy of Sciences Award for Pioneering Work in Switched Co-polymer Antioxidant Systems,
Mendeleev Chemical Society Award for Outstanding Analytical Chemistry Paper,
Ukrainian Technological Academy Award for Outstanding Achievements in Chemistry and Technology of Melanin Pigments,
“Plastpolymer” Society Award for New Technology of Block-co-Polymers
Publications and Patents Summary
He has 132 publications, 35 patents, 1 monograph and 1 text-book chapter in biopolymers

Additional Experience

Training / Seminars
Expert has delivered a number of invited presentations, e.g., “Different strategies for protein formulation in biodegradable polymer particles”, and training sessions, e.g., “Compositional and failure analysis of polymers: practical approach”
Vendor Selection
Expert has extensive experience in selecting qualified vendors of pharmaceutical excipients for various drug delivery systems, formulation development services, analytical chemistry services, and processing/manufacturing services.
He has selected CROs/CMOs for the conduct of different studies that were included in IND/NDA submissions to the FDA
Other Relevant Experience
Expert has an unparalleled expertise in chemistry and technology of MELANIN co-polymers, and their pharmaceutical applications.
As a Full Professor and Chair of Analytical Chemistry, Expert taught different courses of Chemistry in well-known University,
As a Scientific Advisor, Expert prepared 10 Ph.D.s

Language Skills

Language Proficiency
Russian Native

Fields of Expertise

analytical chemistry, biodegradable material, block polymer, chemical process modeling, controlled-release drug delivery technology, copolymer formulation, excipient, Food and Drug Administration compliance, gel permeation chromatography, hydrolysis, kinetics, physiochemical property, plastic medical device, plasticizer, polymer compatibility, polymer degradation, rheological property, biodegradable system, stimuli-responsive system, polymer drug conjugate, excipient compatibility, vaccine delivery, analytical method optimization, active pharmaceutical ingredient, high-performance liquid chromatography detector, polylactic acid, in vivo biodegradable polymer, drug release polymer, benzodiazepine, polymer aging, biocompatibility testing, demineralized water, drug formulation, hydrogen absorption, shear rate, low viscosity, high viscosity, glycolic acid, free radical, inhaler, education, solid-state nuclear magnetic resonance, gas chromatography/mass spectrometry, protein isolation, capillary rheometer, water diffusion, viscometry, deionized water, application development system, acid hydrolysis, alkalinity, gas chromatography application, pharmaceutical quality assurance, contact angle measurement, colloid technology, chemical technology, biomedical coating material, ring-opening polymerization, cationic ring-opening polymerization, surface tension measurement, chromatography data acquisition, isopropyl alcohol, polymer science, characterization process, thermochemical property, chemical characterization, chemical property, viscous fluid, polymer modifier, near-infrared spectroscopy, supercritical fluid chromatography, particle-size distribution determination, viscosity measurement, acrylic compound, crosslinking agent, qualitative chemical analysis, plastic biodegradation, material property, ultraviolet absorption spectroscopy, prolonged-action drug, acetal copolymer, specific heat, heat capacity, rheological measurement, fluid rheology measurement, nuclear magnetic resonance, Food and Drug Administration regulation, data, copolymer, Raman spectroscopy, enzyme kinetics, mixture, transesterification, polymerization kinetics, polymer chemistry, polyethylene, pharmaceutical chemistry, pH chemistry, organic acid, monitoring, methacrylate, medical device, liquid chromatography/mass spectroscopy, Good Manufacturing Practice, emulsion polymerization, electron paramagnetic resonance spectroscopy, differential thermomechanical analysis, dosage form, chemical engineering, carboxylate, buccal drug delivery

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