ComplianceOnline, Online Event
2012-08-16
Why Should You Attend: This seminar will cover the various container closure systems that are available for use with liquids, lyophilized products (bulk and single use), suspensions, emulsions, and bulk powders.
As formulations get more complex, due to the chemical and physical instability of many of the new biologically based molecules (monoclonal antibodies, vaccines, etc.), the container closure systems have to adapt as well. Understanding how the container closure system can affect product stability, and knowing what options are available from the different manufacturers, is critical in ensuring long term stability and closure system integrity.
In addition to discussing various vial and stopper configurations, specialized systems, including prefilled syringes, will be discussed along with the different specialized coating options that are available for these systems. Learning Objectives: Attendees will - Learn how to identify the different types of vials and stopper for specific needs.
- Understand what types of special formulations and coatings are available and when to consider these.
- Learn how to choose a pre-filled syringe and things to consider for long term stability.
- Understand tray drying and specialized containers for bulk freeze-drying.
Areas Covered in the Seminar: - Vial types/formulations.
- Vial leachables and extractables.
- Vials and specialized formulations and coating.
- Stopper types/formulations.
- Stopper leachables and extractables.
- Stopper and specialized formulations and coating.
- Prefilled syringes.
- Tray drying and specialized trays.
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Invited Speakers:
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J. Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies where he develops formulations and lyophilization cycles. 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 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 3-day course called Lyophilization Technology which he teaches through the Center for Professional Advancement. He routinely lectures around the world on formulation, stabilization and process development of lyophilized products. He has also been an active member of AAPS since 2001.
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