ComplianceOnline

4 hour Virtual Seminar - Lyophilization Technology: Background, Physical Properties Characterization, and Developing a Sound Formulation that is cGMP Compliant

Instructor: J. Jeff Schwegman
Product ID: 702009
  • Duration: 4 hrs

Training CD

$899.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 4-hr lyophilization webinar will cover all of the aspects of understanding a freeze-dryer, the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product.

Why Should You Attend:

This seminar will begin by covering a short history of the lyophilization process, the equipment used, types of samples that can and cannot be freeze-dried, and the types of temperature and vacuum sensors used to monitor our products and processes.

Next the discussion will turn to discussing ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques. The information obtained from these specialized studies is critical in developing optimized lyophilization cycles and formulations without having to use a “trial and error” approached, which is still commonly used by many companies who don't understand the science behind freeze-drying.

Finally, the seminar will finish with a discussion focused on using what was learned above to develop an optimized, cGMP compliant formulation.

At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying the principles gained from this webinar, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.

Areas Covered in the Seminar:

  • Brief history
  • Basic system components
  • Temperature and vacuum monitoring devices
  • Crystalline vs. amorphous vs. mixed systems
  • Eutectic melting, glass transition, and collapse temperatures
  • Partial collapse vs. meltback
  • Principals of thermal analysis
  • Thermal analysis equipment and techniques: DSC, DTA, TEA
  • Freeze-dry microscopy equipment and techniques
  • Preformulation assessment
  • Selecting acceptable formulation components
  • Buffers and buffer capacity
  • Antioxidants, stabilizers, surfactants, bulking agents, complexing agents, cosolvents
  • Biomolecule stabilization theory
  • Excipient considerations
  • Infrared analysis of proteins

Learning Objectives:

  • Understanding the different components of a freeze-dryer
  • Understanding the correct temperature and vacuum sensing devices for a specific application
  • Understanding the thermal properties of a formulation (crystalline, amorphous, mixed)
  • Understanding the critical temperatures (Tg', Te, Tc) of a formulation
  • Understanding different excipients in formulations and how they affect the thermal properties
  • Understanding issues associated with large molecule (monoclonal antibodies, globular proteins, etc)formulation and freeze-drying

Who Will Benefit:

This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing.

  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance

Instructor Profile:

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.

Topic Background :

The Food and Drug Administration (FDA) is becoming more and more educated in the practice and science of lyophilization.  As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc.

It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg' or eutectic melting temperature, Te), etc.  Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.

The topics described in this session will cover all of the aspects of understanding a freeze-dryer, the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product.  At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them.  By understanding and applying these principles, companies have a much greater chance of getting products approved by the Regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.

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