Capsugel expands late-stage inhalation product development capabilities
Installation of state-of-the-art Harro Hӧfliger encapsulation unit expands clinical- and commercial-scale capacity for dry powder inhalation applications.
Capsugel has expanded its late-stage inhalation capabilities to advance dry powder inhalation (DPI) concepts through late-stage clinical trial and commercial production. The company has completed installation and validation of a new Harro Hӧfliger Modu-C MS encapsulation unit at its Bend, Ore. facility that includes specialized drum-dosing technology for use in DPI development projects utilizing spray-dry processing. The investment strengthens Capsugel’s full-service inhalation product-development capabilities, which include proprietary spray-dry processing, specialized CMC/analytical services, and encapsulation capacity to support development, clinical trial and commercial scale projects.
“Drug delivery via the lung is becoming an increasingly viable treatment option for a wide range of therapeutic areas, including infectious diseases, genetic disorders and acute systemic conditions that have traditionally been treated via other delivery routes,” said Devon DuBose, Head of Inhalation Product Development at Capsugel’s Bend, Ore. facility. “Spray-dry processing is finding greater utilization in DPI applications because of its superior particle size control, higher drug loading and fewer formulation dependencies compared to traditional lactose blend formulations. Our customers are seeking partners with not only advanced particle engineering technology and expertise, but also integrated inhalation product development solutions that minimize program risk and complexity.”
Capsugel’s new Harro Hӧfliger Modu-C MS encapsulation unit includes an operational capacity of more than 72,000 capsules per hour. The premier technology provides 100% monitoring of dosed powder mass, fill weight ranges between 5 mg and 50 mg, and dose accuracy of RSD<3%. The unit complements Capsugel’s Xcelodose 600S equipment that supports capsule filling for Phase I and Phase II trials. Capsugel’s capabilities for DPI formulations include spray drying for all clinical phases and commercial manufacturing, formulation development and scale-up expertise, phase-appropriate encapsulation and full aerosol analytical capabilities in development and GMP.
“Building on 25 years of experience with spray-dry technology and with formulating more than 1,000 compounds for oral delivery, this expansion is part of our long-term effort to bring our particle engineering, spray-dry processing capabilities and encapsulation expertise to pulmonary drug delivery and growing DPI applications,” said David Lyon, Ph.D., Head of Biotherapeutics, Capsugel. “By broadening our inhalation product development capabilities, we are positioned as an industry leader in specialized oral delivery and in bringing innovative therapies to market.”
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance