Lyophilization: Optimized Pre-Formulation, Formulation, and Cycle Development Techniques Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>This 90-minute <b><i>accredited</b></i> 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.<br><br> 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.<br> <p><b>Module 1:<br> Pre-Formulation Development</b><br>   • Developing a pH Stability Profile<br>   • Developing a pH Solubility Profile<br>   • Conducting a Cosolvent Solubility Screen<br>   • Determining Thermal Stability<br>   • Determining Light Stability<br>   • Determining Oxidation Potential<br>   • Specialized Studies for Bio-Molecule Formulations</p> <p><b>Module 2:<br> Formulation Development</b><br>   • Designing a Buffer System<br>   • Solubility Enhancement<br>   • Choosing Bulking Agents<br>   • Evaluating Stabilizers<br>   • Conducting Accelerated Stability Studies<br>   • Evaluating Container Closure Systems</p> <p><b>Module 3:<br> Lyophilization Cycle Development</b><br>   • Developing an Optimized Freezing Protocol<br>   • Developing an Optimized Primary Drying Protocol<br>   • Developing an Optimized Secondary Drying Protocol<br>   • Determining if an Annealing Step is Necessary and<br>    Designing One Correctly<br>   • Conducting Solid State Characterization of the Finished<br>     Product<br> <b>Question and Answer Session</b></p>