A critical step in the fill-finish manufacturing process, lyophilization removes water from the product after it has been frozen. Modern lyophilization systems utilize an inert gas and pressurization and rapid depressurization to create instantaneous ice nucleation throughout the product, massively improving heterogeneity, and therefore quality. During drying, the chamber is placed under a vacuum, allowing the ice to change directly from a solid to a vapor without passing through a liquid phase. Process control during freeze-drying is imperative to the product integrity.
Today, fill-finish manufacturing demands scalability and flexibility – especially for small batches of specialized therapies. Small batch manufacturing does not run efficiently and cost-effectively on conventional, larger production lines, therefore necessitating scalable, lyophilization platforms where the product - irrespective of development stage - can be manufactured under sterile, GMP compliant conditions.
Learn more how the new SP’s Versa-Line approach offers a compact and flexible units customization throughout the entire aseptic fill-finish manufacturing process.