Case Studies on Failed Cycles and/or Formulations of Lyophilized Products

J. Jeff Schwegman, Ph.D.

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Background: 

This webinar will initially give a background on the basics of freeze-dried products and the freeze-drying process.  Special attention will be given to the thermal properties of a product (glass transitions, eutectic melts, etc.), and how these properties are affected by heat, residual moisture, and different excipients.  Several case studies in failed freeze-dried products due to poorly designed cycles, and or poorly designed formulations will be presented in an interactive format., in which attendees will be presented with all of the data from the failed batch and will be given time to respond as to why the batch failed, and what should be changed to prevent future failures.

Why should you attend:

Failed batches of lyophilized products are unfortunately an all too common event on those companies producing freeze-dried products, including pharmaceuticals, diagnostics, foods, vaccines, etc.  Since freeze-drying is the most expensive unit operation of a manufacturing process, it is in a company’s best interest to keep failures to a minimum, and if they do occur, being able to quickly diagnose the failure and prevent it from happening again.  By having a good understanding of the factors that can result in failed batches and taking a methodical approach to determine why the failure occurred, the development scientist is in a much better position to quickly correct failures and prevent them from happening in the future, saving the company both time and money.

Areas Covered in the Session: 

  • Failed Products/Cycles
  • Description of failure with sample images
  • Cycle parameters and printouts
  • Formulation details
  • Corrective actions to correct failures

Learning objectives:

·        Critical temperatures in freeze-drying (Tg’, Te, Tc)

·        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

·        Correctly diagnose failed batches and suggest changes to the cycle and or formulation to prevent the failure from reoccurring.

 

Who will benefit: 

This webinar will provide valuable assistance to those companies involved in the development and scale-up of therapeutic and diagnostic lyophilized products.

 ·        Quality Control Scientists

·        Development Scientists

·        Production Management

·        Quality Assurance

Keywords:

freeze-drying, lyophilization, cycle design, primary drying, secondary drying, scale-up, cycle transfer

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: J. Jeff Schwegman, Ph.D.,

J. Jeff Schwegman, Ph.D. iscurrently 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 thermalcharacterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes inspeaking and consulting in parenteral pre-formulation, formulation, analytical,and lyophilization of both small molecules and large biomolecules. He also holds patents and develops newtechnologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in1992 and began working at Cook Imaging in Bloomington Indiana, where he gainedexperience in analytical, formulation and process development. In 1999 he began graduate study in theDepartment of Industrial and Physical Pharmacy at Purdue University under thedirection of Dr. Steve Nail, where his focus of research involved studyingchanges in the physical structure of biological molecules duringlyophilization. Dr. Schwegman receivedhis PhD from Purdue University in 2003, and returned to Bloomington where heworked at Baxter Pharmaceutical Solutions as a Research Scientist in thePharmaceutical Development group. InNovember 2005, he left Baxter and formed BioConvergence LLC with 3 otherfounders which specialized in developing new formulations and manufacturingprocesses for parenteral products. InFebruary 2008, he left BioConvergence, which has become a successful company,to form AB BioTechnologies. He iscurrently the course Director for a 4-day course called “LyophilizationTechnology, a Hands-On Approach”, which he teaches through SP Scientific. He routinely lectures around the world onformulation, stabilization and process development of lyophilized products.


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