| Biography | - Consultant supplying technical and attorney support (expert witness), especially biotechnology with stress on biochemistry, protein and enzymatic transformations, purification & separations science processes, involving genetically modified mammalian and microbial biologics. Most recently focus has been on enzyme/ protein/ polypeptide injectables production and purification, in, for example, enzyme replacement therapy (e.g., Hunter Syndrome / Mucopolysaccharidosis, injectable biologic iduronate-2-sulfatase, the enzyme that is deficient or absent in people with Hunter syndrome); biologically active polypeptides (e.g., glatiramer acetate / mannitol injectable for multiple sclerosis treatment); monoclonal antibodies (e.g., extraction and purification of recombinant ranibizumab injectable [agent slows growth of abnormal new blood vessels]); enzyme-based cholesterol test strips; well versed in regulatory compliance (OSHA and EPA regulations); attorney support in civil cases of consumer and worker injury; also, past projects have addressed continuous fixed-film processes / biological treatment of hazardous wastes
- Specialties: Pharmaceutical applications; Continuous processes; process optimization; immobilized enzymes and cells; fixed film microbiological reactors; chemical and biochemical reactions and analysis; separations and purification; chromatography, microorganisms; biological treatment of hazardous wastes; environmental; antimicrobial agents; patent infringement services; claim construction; regulatory compliance; hazard analysis / Food safety, HACCP, SSOPs; extensive international experience
- Experienced as expert witness (expert opinion, IPR / inter partes report, deposition, evidentiary hearing) in above areas. | |