Lyophilization: Optimized Pre-Formulation, Formulation, and Cycle Development Techniques
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries including:
• Biochemists, Chemists
• Chemical Engineers
• Microbiologists
• Pharmacists
• R&D Personnel
• Pilot Plant Operations
• Production Supervisors
• Managers
• QA/QC professionals
Description
This 90-minute accredited online course is designed to provide an introduction to the basic scientific principles of conducting optimized pre-formulation, formulation and cycle development studies for products requiring lyophilization. This course will provide insight into determining and then designing the optimal conditions for the molecule of interest through targeted preformulation
and formulation studies. Insight will then be provided into the process of developing an optimized lyophilization cycle around that formulation.
By understanding the specific characteristics of the molecule of interest through pre-formulation and formulation development studies, the development scientist will be able to develop robust, stable formulations and lyophilization cycles in a much more efficient manner, in addition to being able to troubleshoot.
Module 1:
Pre-Formulation Development
• Developing a pH Stability Profile
• Developing a pH Solubility Profile
• Conducting a Cosolvent Solubility
Screen
• Determining Thermal Stability
• Determining Light Stability
• Determining Oxidation Potential
• Specialized Studies for Bio-Molecule
Formulations
Module 2:
Formulation Development
• Designing a Buffer System
• Solubility Enhancement
• Choosing Bulking Agents
• Evaluating Stabilizers
• Conducting Accelerated Stability Studies
• Evaluating Container Closure Systems
Module 3:
Lyophilization Cycle Development
• Developing an Optimized Freezing Protocol
• Developing an Optimized Primary Drying Protocol
• Developing an Optimized Secondary Drying Protocol
• Determining if an Annealing Step is Necessary and
Designing One Correctly
• Conducting Solid State Characterization of the Finished
Product
Question and Answer Session