Preformulation And Formulation Development of Small And Large Molecules For

Jan 02, 18 Preformulation And Formulation Development of Small And Large Molecules For

Preformulation And Formulation Development of Small And Large Molecules For a Lyophilized Product

The information attained from these specialized studies is crucial in developing optimized lyophilization cycles and formulations without needing to use a “learning from your errors” approached, which continues to be commonly utilized by many companies who hardly understand the technology behind freeze-drying. Next, webinar will concentrate on using that which was learned above to build up an optimized, cGMP compliant formulation that’s specifically created for lyophilization. Comprehensive discussions will end up being included on a pre-formulation evaluation, pre-formulation research including choosing an optimum option pH and buffer program, solubility enhancement, managing oxidation, and bulking brokers. Additionally, period will be focused on tying everything discovered from the pre-formulation research into designing an optimum formulation tailored designed for our molecule of curiosity. Finally, the webinar will conclude with a dialogue on the specialized areas of creating a formulation for huge, biomolecule formulations, and the analytical methods used drive this technique.

Why you need to attend: Companies developing brand-new formulations and lyophilization cycles should be in a position to explain, scientifically, why they have chosen each excipient they have put into a formulation, why they are employing just as much as they have added, what exactly are the critical temperature ranges of the merchandise (glass transition temperatures, Tg’ or eutectic melting temperatures, Te), etc. Businesses that cannot make this kind of information run the chance to be delayed in obtaining their items approved and available on the market, that may have a dramatic effect on their profit percentage. The topics referred to in this session covers all of the areas of understanding the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, blended), the analytical methods utilized to characterize these systems, and how all this details is used to build up a well balanced, optimized, cGMP compliant item. By the end of the program, the attendee can create a well-defined process when planning on taking an empirical method of creating formulations and the lyophilization cycles utilized to dried out them. By understanding and applying these principles, businesses have a much better chance of getting items accepted by the Regulatory firms than those businesses that employ the “learning from your errors” method of formulation and lyophilization routine design.

Areas Covered in the Program:Pre-formulation assessmentSelecting acceptable formulation componentsBuffers and buffer capacityAntioxidants, stabilizers, surfactants, bulking brokers, complexing brokers, cosolventsCrystalline vs. amorphous vs. mixed systemsEutectic melting, cup changeover, and collapse temperaturesThermal characterization techniquesFilling and fill up volumeBiomolecule stabilization theoryExcipient considerationsInfrared evaluation of proteinsLearning goals:Understanding the thermal properties of a formulation (crystalline, amorphous, blended)Understanding the critical temperature ranges (Tg’, Te, Tc) of a formulationUnderstanding different excipients in formulations and how they influence the thermal propertiesUnderstanding buffers and buffer systems, bulking brokers, tonicity modifying brokers, anti-oxidants, co-solvent systems and solubility improving methods, stabilizers, surfactants, and cup transition temperatures modifying excipientsUnderstanding issues connected with huge molecule (monoclonal antibodies, globular proteins, etc)formulation and freeze-drying

WHO’LL Benefit: This webinar provides valuable assist with those companies involved developing formulations and lyophilization cycles, or in lyophilization product manufacturing. Those that would reap the benefits of this webinar consist of:Quality Control ScientistsDevelopment ScientistsProduction ManagementQuality Assurance