Critical Factors Of Fill Finish Manufacturing For Large Molecules

With the explosion of the large molecule (biologics) market, which now accounts for an estimated 20% of all pharmaceutical sales, the industry has entered a new era of drug development. This growth — 10% to 15% each year — is being driven by monoclonal antibodies (mAbs), which are anticipated to have worldwide sales of over $240 billion by 2025.

However, with this expanding market comes some considerable challenges for drug manufacturers due to the fragile nature and instability of these large, complex molecules. As compared to small molecules, large molecules generally require special handling procedures for the bulk drug substance, formulation, and sterile filtering and filling of the final drug product, which is forcing changes at nearly every level of the manufacturing process.