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Fast Track to Final Drug Product: Understanding Costs, Challenges, and Timelines in Personalized Medicine Manufacturing

May 6, 2024 at 12:30 pm US EDT

In this webinar, speakers from Berkshire Sterile Manufacturing (BSM) and Argonaut Manufacturing Services will describe the process of manufacturing sterile injectable personalized medicines, focusing on the steps involved, timelines, and financial implications. This session is intended to educate patients, family members, patient advocacy groups, and healthcare professionals on the journey from drug substance (or active pharmaceutical ingredient, API) to a sterile liquid drug in its final container ready for injection into the patient.  

Scott Goldstein, the Vice President of Strategic Partnerships at Argonaut Manufacturing Services. Based in Carlsbad, CA, Argonaut is a cGMP contract manufacturing organization specializing in custom manufacturing and supply chain solutions for innovators in the biopharmaceutical, life science, and molecular diagnostics industries.  With a career deeply rooted in drug product operations, Scott has held various leadership roles, dedicating 13 years to the field. He managed multiple aseptic filling lines across three facilities and served as the primary subject matter expert (SME) for tech transfer of new products, regulatory audit support, and client engagement within the Drug Product organization.  In the past 4+ years, Scott has seamlessly transitioned his technical expertise into sales and business development leadership roles. Since joining Argonaut in 2021, he has been fervently committed to fostering partnerships with clients to deliver the exceptional service and solutions that define Argonaut Manufacturing Services.

Shawn Kinney, PhD, President, Sterile Division

Dr. Kinney is a seasoned executive with 40 years of experience in sterile drug product manufacturing. He began his career as a sterile fill operator in the mid-1980s, progressing through roles in Quality Control, Quality Assurance, and Operations. Before founding Berkshire Sterile Manufacturing (BSM), he established and led a sterile drug manufacturing company that was later acquired by AMRI, now known as Curia. At BSM, he developed a flexible and isolator-based aseptic manufacturing organization that catered to clinical scale and small-volume commercial manufacturing. In 2023, BSM developed a low-loss fill process to dramatically reduce line losses for very small batches of drug product. BSM was acquired by Sharp in October 2023, and Dr. Kinney remains at BSM, now a subsidiary, as President of the Sterile Division.

Dr. Kinney is also a committed member of the Parenteral Drug Association, co-chairing conferences and participating in task forces related to Pre-Filled Syringes. His academic credentials include a Doctorate in Chemistry from the University of Massachusetts at Amherst, an MS in Medicinal Chemistry from Northeastern University, and a Bachelor of Science from Southeastern Massachusetts University (now UMass Dartmouth).



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