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An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market. 

United States Pharmacopeia (USP) held a two-day workshop, Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.

Particles in drug products can come from many sources—extrinsic (from outside the process), intrinsic (from within the process) and even inherent (as part of the drug formulation)¹.

Trend #1 – Particulate, particulate, particulate

This industry buzzword of the last few years is not going anywhere in 2015. Particulate reduction will continue to be the area of focus for all container closure systems, including the traditional vial/stopper/seal combination. For glass and elastomer manufacturers, the emphasis will be on reducing foreign material in the manufacturing process through enhanced gowning and environmental controls, elimination of sources of cellulose, equipment maintenance, and placing increased pressure on their raw material suppliers. Pharmaceutical companies will need to evaluate if older components will meet the modern particulate requirements of the market.