Vaccine Manufacturing Operations Co-Op Experience
I had the opportunity to work in Building 50, a brand new state-of-the-art Live Virus Vaccine (LVV) Lyophilization (LYO) filling facility located in West Point, PA that’s transforming how live virus vaccines are formulated and filled. What makes LYO so special, compared to it’s Liquid (LIQ) counterparts, is lyophilization.
Lyophilization, in its simplest form, is controlled freeze drying. Using simple chemistry regarding states of matter, vials of finished formulated product are cooled below the triple point, the point where solid, liquid, and gas can all coexist. This allows for sublimation to occur rather than melting, which is the first step of drying in the lyophilization process in Building 50. The second step of our lyophilization process is desorption, leaving only solid material that cannot engage in chemical reactions and contains no biological activity.
Typically, lyophilization is employed to stabilize drug substances, including biological molecules, without altering the quality of drug products. Currently, approximately 50% of biopharmaceuticals in the market are freeze-dried products, implying the critical role of lyophilization as a formulation strategy.
As part of the Operations team, I contributed to several key initiatives, including time source documentation, the changeover process flow diagram and checklist, line speed optimization, and a material management tool. Beyond project work, I toured multiple facilities at West Point and Merck’s headquarters in Rahway, NJ, which gave me a broader perspective on the company’s impact.
