BioSpectra, Inc.
Wayne Talamonti has extensive work experience in the pharmaceutical industry. Wayne is currently the Director of Laboratory Services at BioSpectra, Inc. starting from December 2022. Prior to that, they worked at Novartis for over 22 years, holding the role of Associate Director Science & Technology, Analytical Project Management. Wayne joined Novartis in October 2000 and stayed until December 2022. Before Novartis, Wayne worked at Schering Plough for 12 years as a Scientist II from July 1988 to October 2000. Wayne'searlier experience includes working as a Scientist at R. P. Scherer from an unspecified start date until 1988.
Wayne Talamonti obtained a Bachelor of Science degree in Chemistry from Florida Southern College. The duration of their education at Florida Southern College was from 1976 to 1980.
BioSpectra, Inc.
BioSpectra is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including actives, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Our focus is small molecule synthesis and true, phase-change multi-step purification for both traditional and biopharmaceutical applications. Our services include contract GMP product development, coupled with ongoing commercial manufacturing and regulatory support, up to and including DMF submissions. All of our manufacturing processes are fully validated. Our U.S.-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Onsite analytical testing capabilities include multi-compendial and custom specifications, with full traceability and transparency of all raw materials and sources. Our commitment to quality, compliance and true, U.S.-GMP manufacturing, testing, and regulatory support is unparalleled. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have. GMP Product Categories: • Bulk GMP biological buffers • Active & functional excipients • GMP process chemicals and bulk GMP Solutions Custom GMP Services: • Purification of key ingredients • Full GMP product development • Small molecule custom synthesis • API development and manufacturing • Custom GMP compounded solvents and solutions Comprehensive Quality and Regulatory Program: • FDA registered and inspected • Document support (DMF submissions) • Global GMP requirements (US, IPEC, ICH-Q7)