December 4, 2024
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Sponsored by Sartorius
Cell and gene therapies are next-generation biologics offering treatments and cures for diseases previously thought to be incurable. As such, they address critical, unmet clinical needs. The recent surge in approvals underscores the rapid progress in the field and the growing opportunity for new treatments. The demand for these innovations is rising, with the potential of cell and gene therapies now extending far beyond the treatment of rare and ultra-rare diseases.
The increased attention has also highlighted the need for manufacturers to develop tools that expedite the commercialization of their products, thereby increasing patient access to effective therapies. However, as a unique class of treatments, cell and gene therapies present new manufacturing challenges. Often, existing equipment and consumables used in the production of traditional biotherapeutics are not optimal for cell and gene therapy processes. The relative nascency of the field also means that deep process understanding is lacking. Combined with the complexity and diversity of these therapies, there is an absence of standardized production platforms. Tackling these challenges is associated with long timelines and high costs, but neglecting to take the appropriate measures increases the risk of trial failures.
Sartorius shares your mission to bring life-changing cell and gene therapies to patients. In our new white paper, "Setting the Standard in Cell and Gene Therapy: Perspectives on Performance, Scalability, and Regulatory Compliance,” we examine three key challenges associated with the process development and manufacturing of cell and gene therapies:
Reproducible Performance: Cell and gene therapy process development is often slow and expensive due to a lack of deep process understanding, time-consuming manual operations, and batch-to-batch variability.
Streamlined Scalability: Without scalable tools and production methods, transferring cell and gene therapy processes from development to large-scale production can lead to inconsistent results and costly revalidation efforts.
Regulatory Compliance: Cell and gene therapy manufacturers must be prepared to adhere to the latest regulatory guidance in a rapidly changing landscape.
Enriched with expert insights, our white paper explores these themes in detail within two modalities—stem cells and adeno-associated viruses (AAVs)—highlighting the distinct challenges each presents. We then detail how you can accelerate commercialization with end-to-end solutions that prioritize performance and scalability with a simplified path to regulatory approvals. Together, we're setting the standard in cell and gene therapy. Click here to read more.
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