Catalent, Inc. the leader in enabling the development and supply of better treatments for patients worldwide, has completed upgrades in its capsule filling of Dry Powders for Inhalation and capsule blistering suites in Boston, MA USA, to handle potent drugs. These upgrades, including the addition of capacity for both development and commercial spray drying, now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders. The upgrades include isolators for potent compound processing and cleanroom upgrades for the safe handling and containment of powders through the installation of misting showers and airlocks. The capsule filling lines use drum dosing technology with in-line AMV (advanced mass verification) sensor technology, and flexibility for custom powder feeding based on complex powder characteristics. “We are delighted that we are now able to handle potent drugs in Boston and do so in a low relative humidity (<10%) environment to maintain powder stability with strict microbial controls,” said Gordon Ashton, site General Manager for Catalent’s Global Center of Excellence for spray drying. “The site’s annual capacity has increased to 300 million capsules, one-third of which can be employed for potent drugs.”
The Boston facility is Catalent’s Global Center of Excellence for large scale spray drying and Dry Powder Inhaler (DPI) capsule manufacture and packaging. It features inhaled powder spray drying with three PHARMA-SD spray dryers (PSD-1, PSD-4 and PSD-7), as well as three developmental and commercial-scale lines for capsule filling and capsule blister packaging. By pairing Boston’s clinical to commercial-scale spray drying and manufacturing capabilities with the inhalation formulation and analytical development expertise at Catalent’s Morrisville, NC USA facility, Catalent’s network can help advance inhaled molecules from any point in development through product launch and beyond.