Merck News :-) Merck cites EnWave’s REV™ Technology as a Faster, Viable Drying Alternative to Vial-Based Lyophilization for Vaccines and Biologics
2021-01-26 09:00 ET - News Release
VANCOUVER, British Columbia, Jan. 26, 2021 (GLOBE NEWSWIRE) --
EnWave Corporation (TSX-V:ENW | FSE:E4U) (“EnWave”, or the “Company”) announces today that Merck & Co. Inc (“Merck”) published a research paper citing EnWave’s freezeREV® process as a viable manufacturing alternative to vial-based lyophilization for vaccines and biologics. The research article entitled “Evaluation of Microwave Vacuum Drying as an Alternative to Freeze-Drying of Biologics and Vaccines: The Power of Simple Modeling to Identify a Mechanism for Faster Drying Times Achieved with Microwave” was published in the January 19, 2021 edition of PharmSciTech, the official journal of the American Association of Pharmaceutical Scientists.
Merck’s nine-month evaluation used a lab-scale freezeREV® unit manufactured by EnWave specifically for the dehydration of pharmaceutical products. The goal of the study was to determine the uniformity and repeatability of Microwave Vacuum Drying (MVD) when used to dry liquid vaccines in vials. This evaluation is the first of its kind to scientifically document the efficacy of microwave-vacuum drying, more specifically freezeREV®, for the drying of vaccines.
The authors of the research article note that both the global pandemic and the rapid spread of COVID-19 have emphasised the need for accelerated vaccine development and on-demand, flexible manufacturing options. The published evaluation results stated that “Microwave vacuum drying serves as a faster alternative to freeze drying of biologically active materials such as vaccines, proteins, and microorganism cultures”. Data from the study shows that EnWave’s freezeREV® process reduces drying cycle times by 80% to90% while maintaining product activity and stability when compared to lyophilization. Lyophilization drying times are seen as a significant bottleneck for vaccine manufacturing. The research article also confirmed that EnWave’s freezeREV® process demonstrates “comparability between EnWave’s freezeREV® and freeze-dried samples” for drying uniformity and repeatability. The significant decrease in drying times was also accompanied by increased manufacturing flexibility.
Merck has been an EnWave research partner since 2015.
EnWave plans to continue collaborating with GEA Lyophil through a Joint Development Agreement to further refine its freezeREV® technology to potentially benefit Merck’s ongoing work regarding vaccine dehydration.
The full research article can be found at Springer Link.