This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.
This webinar will provide valuable assistance to those companies involved in the packaging of liquids, suspension, emulsions, powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods.
Founder and CEO, AB BioTechnologies LLC
J. Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral pre-formulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field.
Dr. Schwegman received his BS 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 study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization.
Dr. Schwegman received his PhD from Purdue University in 2003 and returned to Bloomington where he worked at Baxter Pharmaceutical Solutions as a Research Scientist in the Pharmaceutical Development group. In November 2005, he left Baxter and formed BioConvergence LLC with 3 other founders which specialized in developing new formulations and manufacturing processes for parenteral products. In February 2008, he left BioConvergence, which has become a successful company, to form AB BioTechnologies. He is currently the course Director for a 4-day course called “Lyophilization Technology, a Hands-On Approach”, which he teaches through SP Scientific. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products.
Choosing the correct container closure system is vital in ensuring long term chemical and physical stability of injectable drug products. Additionally, ensuring that system integrity it maintained over the lifetime of the drug is critical in ensuring that microorganisms do not compromise the product, as this can result in patient illness or death. There are several companies that make the various components that comprise a container closure system for a drug product, and all components are not created equal, nor are they all compatible.
Care must be taken in choosing the correct components to ensure that a proper seal is achieved, and to ensure that the products contained inside don’t have a negative interaction with the container closure system components (physical or chemical). In cases where an interaction is observed, highly specialized formulations and coatings are available. New technologies such as prefilled syringes (liquid and freeze-dried) are now also widely used due to their ease of use and compatibility with kitting operations.
This Webinar will discuss the components that constitute a complete container closure system including the various vials and stoppers that are commercially available. The various components that make up each of these systems will be discussed along with a brief discussion on manufacturing processes. In those cases where a basic container closure system will not suffice, time will be dedicated to discussing the various specialized systems that are available including specialized formulation components and specialized surfaces and coatings. Time will also be dedicated to discussing specialized delivery systems such as prefilled syringes (both liquid and lyophilized), as these constitute a large part of the market of container closure and delivery systems. Finally, a discussion will cover the various systems and methods of preparing and storing lyophilized bulk drug substances or excipients.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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