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The Cell and Gene therapy market has been experiencing double digit growth over the last 3–5 years and is anticipated to continue at this pace. With the move into the late-stage manufacturing and promising outcomes in oncology, regenerative medicine and rare diseases, the advanced therapeutic regulatory landscape has been evolving to respond quickly. With the successful outcomes delivered by the cell and gene therapies coupled with an increasing pressure from emerging diseases, the trend towards fast-track status in the clinical pipeline continues to grow. Consequently, cell and gene therapy providers are employing innovative development and manufacturing technologies to adapt to an accelerated clinical landscape.

Unlike traditional biologics, cell and gene therapy innovators do not have the luxury of a standardized and regulatory-approved production process to onboard their drug targets and scale-up for commercial readiness. Additionally, the growing gene therapy clinical pipeline is outpacing the available manufacturing capacity and process expertise. While there are both pros and cons to building in-house capacity to mitigate demand, there are still risks for innovators if the therapies do not perform in the clinic as expected or if the internal buildout is not completed fast enough for the Fast Track designations. Additionally, investors often prefer that therapeutic companies have a manufacturing partnering plan early in their pipeline. Therefore, it critical that innovators secure manufacturing space early. Custom manufacturers are ideally suited for incurring the risk of building capacity and customizing an efficient process for successful scale-up and efficient late-stage manufacturing. Partnering with a service provider early can help meet fast-paced timelines due to their experience across multiple bioproduction systems and analytical assays. This broad experience allows innovators the advantage of being able to address the nuances of their product and process quickly and effectively.

As there are still a high number of therapies in preclinical phase there will be a heavy push to move these drugs to commercial readiness while managing potential financial burden. Major factors like supply chain complexity, process efficiency and a solid understanding of regulatory requirements around handling human-sourced material, are critical to the success of these medicines. Coupled with supply chain complexity is the inherent challenge that each cell type has its unique biological blueprint making it difficult to move towards a standardized manufacturing system for scalability. Even for gene therapies, although adeno-associated virus (AAV) vectors are leading the way, there are multiple options for delivery, including lentiviruses, retroviruses and others that require custom optimization. The burden of continuous innovation for each project as well as moving biological materials, like cells and viruses, through each step of the operations exacerbates the need for efficiency within the manufacturing process. Custom developers are better suited to manage this burden while balancing the complexities of the biological material.

Catalent has made significant investments in the last year in cell and gene therapy with the acquisitions of Paragon Bioservices and MaSTherCell. Paragon’s deep experience in viral vector scale-up and production in combination with MaSTherCell’s expertise in both autologous and allogeneic cell therapy development and manufacturing allows Catalent to be a full-service global partner for advanced biotherapeutics. An outcome of coupling these acquisitions with Catalent’s broader capabilities across the Biologics industry, is the ability to extend our strategic partnerships and offer cross innovation with adjacent industries. The combined strengths of Catalent and our strategic innovative partners allow for therapies to be manufactured under high-quality standards and unmatched operational excellence in one of the fastest-growing areas of healthcare.

 

For more information visit biologics.catalent.com

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