Capsugel Extends Inhaled Biotherapeutics Delivery Capability to Phase II Clinical Trials
Capsugel has manufactured Phase II clinical trial supplies for a dry powder inhalation (DPI) formulation that efficiently delivers biotherapeutics to the lung. The supplies were manufactured by Bend Research, part of Capsugel’s Dosage Form Solutions business unit. Utilizing a combination of unique formulation, particle engineering and spray-drying processing methods, the inhaled dry-powder biotherapeutic is the first inhalation delivery therapy to be manufactured to PhaseII scale at the company’s clinical trial manufacturing (CTM) facility in Bend, Ore.
“While drug delivery via the lung traditionally has been limited to the local treatment of respiratory diseases, there is growing interest in using these technologies for systemic delivery across a wider range of therapeutic areas, such as infectious disease and genetic disorders,” said David Lyon, Head of Biotherapeutic Formulation and Processing, Capsugel Dosage Form Solutions. “For 15 years, we have worked at various stages of inhalation therapy development. By advancing our offering to include specialized DPI capsules and now clinical manufacturing supplies for biotherapeutic compounds, we are bolstering our ability to help customers bring these innovative therapies to market to benefit patients.”
Capsugel continues to innovate the development of customized formulations for DPI therapeutics, offering customers comprehensive solutions to address inhalation delivery challenges. Using spray-dry technology, Capsugel provides unparalleled particle engineering for inhalation. This results in a stable dry powder with improved aerosol performance and high collection efficiencies. These DPI powders will be dosed in a Phase 2 clinical trial this year, and with additional commercial spray-drying capacity coming online this year, Capsugel will soon be able to manufacture at commercial scale for DPI formulations as well.
“Our clients continue to seek innovative and integrated solutions to their formulation challenges,” said Amit Patel, President, Capsugel Dosage Form Solutions. “Advancing our inhalation formulation offering to Phase II-scale GMP supplies — through the use of our specialized equipment, formulation know-how and capsule expertise — represents another way in which Capsugel is collaborating with customers on the development of better medicines for patients.”
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
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