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Lyophilization Technology: Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant

Instructor: J. Jeff Schwegman
Product ID: 702305
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar on lyophilization technology will provide you the understanding required to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization.

Course "Lyophilization Technology: Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

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 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.

Learning Objectives:

  • 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.

Areas Covered in the Seminar:

  • Pre-formulation assessment.
  • Selecting acceptable formulation components.
  • Buffers and buffer capacity.
  • Antioxidants, stabilizers, surfactants, bulking agents, complexing agents, cosolvents.
  • Crystalline vs. amorphous vs. mixed systems.
  • Eutectic melting, glass transition, and collapse temperatures.
  • Thermal characterization techniques.
  • Filling and fill volume.
  • Biomolecule stabilization theory.
  • Excipient considerations.
  • Infrared analysis of proteins.

Who Will Benefit:

This webinar will provide valuable assistance to those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing.  Those who would benefit from this webinar include:

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

Instructor Profile:

Dr. 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:

Many of the new active ingredients coming out of discovery these days are biologically based, such as monoclonal antibodies, proteins, vaccines, etc. Unlike small molecules, these types of products can be extremely sensitive to manufacturing stresses such as shear, oxidation, freezing, drying, etc. This seminar will begin by covering ways to understand the physical properties of these types of products through the use of very specialized analytical techniques. The information obtained from these specialized studies is critical in developing optimized formulations and lyophilization cycles without having to use a “trial and error” approach, which is still commonly used by many companies who don’t understand the science behind designing a formulation that is destined to be freeze-dried. Next, the webinar will focus on using what was learned above to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization. In depth discussions will be included on a pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, stabilizers, and bulking agents.

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