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  4.  » Catalent Launches New Service for End-to-End Supply Chain Case Management of Cell and Gene Therapies

Catalent Appoints Ricardo Zayas as North American Biologics Operations Leader

SOMERSET, N.J. – January 24, 2023 — Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the launch of its new Case Management Service, which has been specifically designed to address the unique challenges associated with the safe and timely delivery of advanced therapies to patients by providing professional supply chain oversight from program start to finish.

The supply chain logistics for advanced therapy medicinal products (ATMPs), such as cell and gene therapies, is complex because of their inherent sensitivity, high value, and certain patient-specific complexities of delivering each dose. Ensuring these products are efficiently managed and correctly transported reduces the risk of potential disruption to the manufacturing schedule and, ultimately, the administration of the therapy to the patient.

Customers adopting the service will be assigned a Case Manager, who will act as a single point of contact for their project, from beginning to end, regardless of whether the therapy is being manufactured by Catalent or elsewhere. The Case Manager will coordinate the scheduling of material collection, the manufacturing slot for the therapy, arrange shipments and continuously manage its status. They will also ensure that proper documentation and traceability, including chain of custody and of identity, are maintained throughout the product lifecycle, providing around-the-clock support and issue resolution.

“This service combines Catalent’s deep expertise, extensive capabilities, and leadership in cell and gene therapy manufacturing with our robust packaging and clinical supply services to fill a critical need in the successful delivery of these therapies to patients,” said Delara Motlagh, Vice President, Global Cell Therapy for Catalent. “The Case Management Service enables customers, who are often resource-constrained, to focus their resources on the science and development of advanced therapies, and allow highly experienced specialists to manage the complex and highly time-critical supply chain for cell and gene therapies.”

“Customers have repeatedly informed us that they are looking for a streamlined supply chain that optimizes efficiency and also meets the very specific needs of their projects, so we designed this case management program to provide the flexibility and scalability to meet both the immediate and future needs of their studies,” said Trish Demko, Director, Case Management Services at Catalent. “Combined, our case management team has more than three decades of experience of managing the critical logistics for advanced therapies, including assuring the chain of identity and chain of custody, as well as the complex and time sensitive communication needs that these programs present.”

Customers that choose Catalent to manufacture their therapies will gain access to a robust cell and gene therapy development and manufacturing network, including gene therapy manufacturing facilities in Baltimore and Harmans, Maryland, an induced pluripotent stem cell (iPSC) development and differentiation facility in Dϋsseldorf, Germany, and clinical and commercial cell therapy manufacturing facilities in both Princeton, New Jersey and Gosselies, Belgium, which recently opened one of the world’s largest commercial-scale cell therapy manufacturing facilities.

NOTES FOR EDITORS

ABOUT CATALENT CELL AND GENE THERAPY

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies and viral vaccines, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, and oncolytic viruses. As an experienced and innovative partner, it has a global network of dedicated, development, clinical, and commercial manufacturing facilities, including an EMA- and FDA-licensed viral vector facility, and fill/finish capabilities located in the U.S. and Europe. With integrated solutions for plasmid DNA, viral vectors, and autologous and allogeneic cell therapies through clinical trial packaging and logistics, Catalent can provide full supply chain control, helping innovators get their advanced therapies to patients, faster.

ABOUT CATALENT

Catalent 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.

 

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