Lyophilization Process Development and Cycle Design with a Case Study

This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

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Last Recorded Date: Jun-2019

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(PPT + Recorded Training File)

$399.00
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Areas Covered in the Webinar:
  • Thermal characterization including DSC and FDM.
  • Understanding the effects of working with crystalline vs. amorphous components.
  • The problem with working with a metastable glassy system and the use of annealing to correct this problem.
  • Determining optimal shelf temperatures for the freezing step.
  • Determining optimal shelf temperatures and chamber pressures for the primary drying step.
  • Determining optimal shelf temperatures and chamber pressures for the secondary drying step.
  • Characterization of the finished lyophilized product.
Learning objectives:
  • Learning how to interpret a lyophilization cycle chart
  • Developing optimal conditions for freezing, primary, and secondary drying
  • Distinguish between amorphous and crystalline components and how they affect cycle design
  • Understanding the need and techniques of characterizing the dried solids
Who Will Benefit:

This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods. Personnel who will benefit include:

  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance
Instructor Profile:
Jeff Schwegman Jeff Schwegman

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.

Refund Policy

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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