Angel Diez, Telstar’s Lyophilization Technology Specialist, gave a lecture on challenges in aseptic technology and efficient processes for pharmaceutical production.
Telstar participated in the Modern Technologies for Vaccines Production Seminar (Moscow 2019, 12 of March), the international event promoted by the Ministry of Industry and Trade for the Russian Federation. At this event, Angel Diez, Lyophilization Technology Specialist at Telstar, held a conference on challenges in aseptic technology and efficient processes for pharmaceutical production. Besides offering an overview of the process, the lecturer gave an in depth analysis on the needs of freeze dryers and associated equipment for the production of vaccines, like automatic loading systems, cold shelf loading, induced nucleation, production PAT tools, aseptic production, sterility and cross contamination prevention, among others.
Angel Diez informed the delegates that most vaccines are temperature sensitive and thermolabile, but very few are stable in liquid form so they need to be lyophilized. When this method needs to be applied to downstream production a holistic view of the overall process needs to be taken into account, from process development to reliable and stable production equipment and parameters. During both the development and production stages every step of formulation, blending, filling and freeze drying needs to be studied, tested and validated taking into account every parameter that might affect the robustness of the final product. Díez noted that, for this reason, special care needs to be taken for process development with the appropriate equipment and PAT tools to understand the process and the sensitivity to altered conditions to be able to transfer the process to production and define the appropriate performance specifications of the production equipment at the next stage.