$179
Sterile Drug Product Development: Formulation, Stability, and Packaging
Presenter: Jeff Schwegman, Ph.D. Course Description This comprehensive webinar details the end-to-end process of taking a purified drug compound, or active pharmaceutical ingredient (API), and converting it into a stable, sterile, injectable drug product in both liquid and lyophilized (freeze-dried) presentations. The session explores preformulation strategies, focusing on selecting the appropriate pH to achieve optimal chemical stability and aqueous solubility, as well as choosing a suitable buffer system with adequate buffer capacity to maintain formulation pH. The discussion covers functional excipients in detail, including tonicity-modifying agents for osmolality adjustment, solubilizing agents to enhance drug solubility, stabilizers to minimize degradation, and surfactants to help prevent physical instability. For multi-dose products, considerations for the use of antimicrobial preservatives will also be addressed. When developing a lyophilized formulation, the webinar explains how excipient selection must be modified, including the role of bulking agents, and how these formulation decisions influence the critical thermal properties of the product during freeze-drying. Finally, the webinar addresses the selection of an appropriate container closure system based on the formulation and product presentation, including components such as vials, stoppers, and seals. It will also explain how specialized surface coatings and packaging chemistries can influence product stability and potentially improve compatibility between the formulation and the container closure system. Learning Outcomes
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About the Presenter J. Jeff Schwegman, Ph.D., is currently the Founder and Chief Executive Officer of Labyrinth BioPharma, where he develops formulations, lyophilization cycles, and manufacturing processes for injectable drug products, diagnostics, and tissues used in surgery. Additionally, Dr. Schwegman specializes in speaking and consulting on parenteral pre-formulation, formulation, analytical development, and lyophilization of both small and large biomolecules. He also holds patents and develops new technologies in the field of lyophilization. Dr. Schwegman received his B.S. in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington, Indiana, where he gained experience in analytical, formulation, and process development. In 1999, he began graduate studies in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail. His research focused on studying changes in the physical structure of biological molecules during lyophilization. Dr. Schwegman received his Ph.D. from Purdue University in 2003 and returned to Bloomington, where he worked as a Research Scientist in the Pharmaceutical Development group at Baxter Pharmaceutical Solutions. He has founded several companies, including BioConvergence and AB BioTechnologies. He currently serves as the Course Director for a four-day course titled “Lyophilization Cycle Development & Optimization: A Hands-On Laboratory Course,” which he teaches through SP Scientific. He also regularly lectures worldwide on formulation, stabilization, and process development of lyophilized products. Additional Information
After Registration:
You will receive an email with login information and handouts (presentation slides) that you can print and share with all participants at your location.
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you can reach out to the below contact:
Toll-Free No: 1-302-444-0162 Email: care@skillacquire.com Address: 651 N. Broad Street, Suite 206, Middletown, DE 19709 Snippet From Our Previous Session |