Simtra and Millrock Webinar Now Available On Demand
Millrock Technology and Simtra BioPharma Solutions Share Dual Approach to Formulation Development
Millrock Technology recently hosted a technical webinar with Simtra BioPharma Solutions exploring how development teams can evaluate formulations for both liquid solutions and lyophilized solids.
The webinar, “A Dual Approach to Formulation Development Appropriate for Solutions and Lyophilized Solids,” featured Dr. Greg Sacha, Global Senior Scientist at Simtra BioPharma Solutions, and Spencer Holmes, Applications Engineer at Millrock Technology.
Using an antibody-drug conjugate case study, Sacha demonstrated how statistical design of experiments can be used to assess multiple formulation variables efficiently, including buffer type, buffer concentration, pH, surfactant requirements, and stability under accelerated conditions.
The case study also illustrated how early formulation data can help determine whether a molecule is best developed as a liquid solution or lyophilized solid. Additional testing examined how manufacturing considerations, including pump selection, could affect the stability of the formulation.
Building on the formulation findings, Holmes explained how thermal characterization and heat flux data can be used to establish a primary drying design space. His presentation highlighted how measuring vial heat transfer, product cake resistance, sublimation rate, and equipment capability can support cycle development and technology transfer.
Together, the presentations showed the value of connecting formulation, process, and equipment decisions earlier in development. This integrated approach can help teams:
- Identify formulation and manufacturing risks sooner
- Reduce reliance on trial-and-error cycle development
- Establish data-supported operating boundaries
- Improve confidence when transferring a process from laboratory to production scale
The webinar concluded with an audience Q&A covering common formulation challenges, early warning signs for difficult-to-dry products, ADC concentration, buffer selection, bulking agents, and considerations when transferring a lyophilization process to production equipment.
The full webinar is now available to watch on demand.
Watch “A Dual Approach to Formulation Development Appropriate for Solutions and Lyophilized Solids”