Catalent Announces Addition of Potent Capsule Filling Capabilities for Inhaled Dry Powders at its Boston, MA USA Facility
SOMERSET, N.J. – February 2, 2024 – Catalent, Inc. (NYSE: CTLT) 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.
ABOUT CATALENT INHALATION
Catalent Inhalation has the capabilities, expertise, and state-of-the-art facilities to expedite product development, from concept and feasibility studies through commercial manufacture and release testing. With over 30 years of inhalation product experience, Catalent can handle the most complex projects and help bring therapies to market faster. Whether a single service or a comprehensive development package is required, Catalent offers end-to-end expertise in dry powders for inhalation (DPI), unit-dose liquid and powder, bi-dose and preserved multi-dose nasal sprays. Our DPI expertise lies in spray-dried or lactose blended powders for inhalation, encapsulation and blistering. In addition, Catalent provides comprehensive analytical, bioanalytical and clinical supply services.
Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information www.catalent.com.