Alpaslan Yaman, Ph.D.
Senior Drug Product Consultant
Dr. Yaman has expertise in sterile and non-sterile formulation development, process development (including automation) and scale-up, validation, technology transfer and technical services. He has scaled up and validated more than 40 products ranging from sterile powders to lyophilized reconstituted products. His expertise includes both traditional and biotech (peptides, proteins and nucleotide) drugs.
- Gamma irradiation of macromolecules and microwave sterilization,
- Third party manufacturers and service providers in the arena of technical support and quality/compliance,
- Novel delivery systems such as liposomes, microspheres and drug/device combination products.
Dr. Yaman earned his Ph.D. in Pharmaceutical Sciences with a major in Industrial Pharmaceutics and minor in Physical Chemistry. Prior to consulting, he served as Vice President, Technical Operations and Manufacturing at Edge Therapeutics and as Executive Director, Process Engineering, Worldwide Technical Operations at Johnson & Johnson.
- Sterile Formulation
- Due Diligence Audits
- Combo Device Products
- FDA and EMA Experience
- Biotech and Medical Device
- Six Sigma Black Belt
- Blow/Fill/Seal Technology