With the explosion of the 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, which are anticipated to have worldwide sales of nearly $125 billion by 20201. However, this burgeoning market comes with some considerable challenges for drug manufacturers, due to the fragile nature and instability of these large, complex molecules. Specifically, their need to be handled differently than small molecule drugs is forcing changes at nearly every level of manufacturing. The bulk drug substance, formulation, and sterile filtering and filling of the final drug product all require special handling procedures.

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