New process for optimal temperature control of blow fill seal for thermally sensitive medicines, including biologics and large molecule products
The new method of advanced aseptic manufacturing helps to minimize the temperature impact on thermally sensitive molecules, such as biologics, throughout the BFS manufacturing process. (Credit: Pixabay)
Woodstock Sterile Solutions, a leading blow-fill-seal (BFS) contract development and manufacturing organization (CDMO), announced today that it has secured a U.S. patent for a cold BFS packaging and system process.
This new method of advanced aseptic manufacturing helps to minimize the temperature impact on thermally sensitive molecules, such as biologics, throughout the BFS manufacturing process.
“At Woodstock Sterile Solutions, our team is constantly innovating to improve on our industry-leading BFS formulation and manufacturing capabilities to expand the use of BFS technology to more products and markets. We work with a number of organizations in the respiratory and ophthalmic markets, and this patented technology opens up BFS to others in the industry who have expressed concerns about how the use of elevated temperatures during BFS could potentially affect the integrity of heat-sensitive products, including large molecule formulations and biologics,” says Paul Josephs, CEO of Woodstock Sterile Solutions.
The BFS process forms the container, fills it with product and seals it in less than 15 seconds, all under aseptic conditions without human intervention. The process utilizes heat to melt the plastic resin to form the container, and the residual heat generated during this phase of the process could make the product susceptible to heat-related damages, including denaturing and precipitation. This is especially true when it comes to biologics, such as vaccines, proteins, monoclonal antibodies, blood or blood components, allergenics, and gene therapies.
“BFS drastically reduces the contamination risks associated with the primary filling of pharmaceutical liquids, lowering the potential for microbial contamination or foreign particulate as compared to traditional glass vial manufacturing,” says Dr. Waiken Wong, Manager of Development Engineering at Woodstock Sterile Solutions. “We have the most experience in the industry handling large molecules in BFS, and we are looking to expand. With the addition of this patented process, Woodstock has a viable solution that gives us the ability to maintain optimum temperature balance throughout the BFS process. This ensures both the integrity of biologic and other thermally sensitive molecules as well as the BFS containers themselves.”
Source: Company Press Release