Catalent starts manufacture of Passage Bio's lead gene therapy products
The CDMO will provide packaging, labeling and distribution services through its FastChain demand-led supply offering
Production operations are underway at Catalent's dedicated manufacturing suite for genetics medicines-focused Passage Bio after it recently completed the construction and current Good Manufacturing Practice (cGMP) qualification, the contract development and manufacturing organisation said Monday.
The new suite, which is at Catalent's Cell & Gene Therapy facility in Harmans, Maryland, will focus on Passage Bio's product candidates for the treatment of rare monogenic central nervous system (CNS) disorders.
The completion of the dedicated CGMP manufacturing suite results from Passage Bio’s ongoing collaboration agreement with Catalent first announced in July 2019.
To support the production of AAV, Passage Bio is using the Pall Corporation’s iCELLis single-use fixed-bed bioreactor technology. This fully integrated bioreactor system provides a scalable alternative for the cultivation of adherent cells and is capable of meeting demand for both clinical and commercial-scale volumes.
Catalent will deliver Passage Bio’s therapy candidates to clinical trial sites for administration to patients, as well as provide packaging, labeling and distribution services through its FastChain demand-led supply offering, which is particularly well suited to studies of advanced therapy medicinal products where speed, efficiency and flexibility are vitally important.
"Having a dedicated manufacturing suite focused solely on our products allows us to control our critical production supply chain, providing the flexibility and scalable capacity to more rapidly advance our product candidates from clinical trials to commercialization,” said Bruce Goldsmith, president and chief executive officer of Passage Bio.
In addition to its collaboration with Catalent, Passage Bio is also supporting its preclinical programs through its partnership with the University of Pennsylvania’s (Penn’s) Gene Therapy Program, which provides access to preclinical and toxicology research-grade vector supplies.
Alex Fotopoulos, chief technical officer of Passage Bio, said: “Investing in dedicated cGMP manufacturing infrastructure at Catalent, augmented by our access to vector supplies, technology, and expertise at Penn, provides us the flexibility and capacity to advance multiple programs in parallel and to rapidly deliver supplies to support clinical trials worldwide."
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