This seminar will begin by covering 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. Next, 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, and bulking agents. Additionally, time will be dedicated to tying everything learned from the pre-formulation studies into designing an optimal formulation tailored specifically for our molecule of interest. Finally, the webinar will conclude with a discussion on the specialized aspects of designing a formulation for large, biomolecule formulations, and the analytical techniques used drive this process.
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.
Objectives of the Presentation:
To guide in the understanding and performance of:
Who can Benefit:
- 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
This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid pharmaceutical dosage forms, and dried foods.
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