In an advancement for cancer treatment, Gilead Sciences has received FDA approval for a new manufacturing process that accelerates the production of its revolutionary CAR-T therapy, Yescarta. Developed by Gilead’s Kite Pharma unit, this development marks a milestone in the ongoing battle against relapsed or refractory large B-cell lymphoma, a rapidly progressing disease that requires timely intervention.
Kite Pharma
The FDA’s approval enables Gilead to reduce the CAR-T cell manufacturing time for Yescarta from the previous average of seven days down to five days. This enhancement in the production process is not just a technical achievement but a ray of hope for patients awaiting critical care. With this change, the median turnaround time for Yescarta – encompassing the collection of a patient’s T cells, the intricate manufacturing of the genetically re-engineered cells, and the final product release – is now reduced from 16 days to a mere 14 days.

This accelerated timeline is crucial for patients battling large B-cell lymphoma, as Cindy Perettie, head of the Gilead cell therapy business, emphasizes the urgency of treatment due to the aggressive nature of the disease. The reduced wait time for Yescarta could potentially be lifesaving for many patients, providing them with faster access to this vital therapy.

Yescarta has already been making waves in the market, notably outpacing Bristol Myers Squibb’s rival drug, Breyanzi, in terms of product delivery efficiency. With the latest manufacturing improvements, Yescarta sets a new industry benchmark with its 14-day median turnaround time, significantly shorter than the 24 days targeted by Breyanzi.

However, the impact of manufacturing time on patient treatment is profound. Clinical trials have shown that the time taken to produce individualized therapies can result in disease progression for some patients while they wait. In Gilead’s ZUMA-7 trial, for instance, a small proportion of patients could not receive Yescarta due to the advancement of their condition during the manufacturing period.

Experts in the field, like David Porter from Penn Medicine, acknowledge the importance of these advancements. While he suggests that the reduction from 16 to 14 days might not be a major clinical leap, he agrees that any reduction in time is beneficial in preventing cancer progression.

Behind the scenes, this manufacturing efficiency is driven by Gilead and Kite’s efforts to optimize their processes, aiming to reduce quality control testing and processing steps. Chris McDonald, Kite’s global head of technical operations, points out that these enhancements are expected to lower overall costs and boost manufacturing capacity at their facilities in the United States. However, the specifics of these process improvements remain confidential, part of Gilead and Kite’s strategy to maintain their competitive edge.

While this update currently applies only within the United States, with international implementation pending additional regulatory approvals, it represents a significant stride in CAR-T therapy. Before this update, Gilead was already leading the race with the fastest turnaround times for its cell therapies, including Yescarta and Tecartus.

As the field of CAR-T therapy continues to evolve, Gilead’s latest achievement in reducing the manufacturing time of Yescarta stands out as a testament to the ongoing efforts to enhance cancer treatment and patient care. This development not only sets a new standard in the efficiency of delivering life-saving therapies but also underscores the importance of continual innovation in the fight against cancer.

Source:
1. https://endpts.com/gilead-kite-shorten-yescarta-manufacturing-by-two-days-in-incremental-improvement/
2. https://www.fiercepharma.com/manufacturing/gileads-kite-wins-fda-nod-new-car-t-manufacturing-process-speed-yescarta-turnaround?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FiercePharmaManufacturing&oly_enc_id=4567B8987523J5I
3. https://www.gilead.com/news-and-press/press-room/press-releases/2023/12/us-fda-approves-label-update-for-kites-yescarta-car-tcell-therapy-to-include-overall-survival-data
GMP mRNA
Check out our AAV CDMO service to expedite your gene therapy research
About PackGene

PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

Related News

How to make mRNA therapeutics safe from the start

The success of mRNA vaccines against COVID-19 has unleashed a flood of interest in using the technology to create more vaccines and treatments for everything from rare diseases and infections to cancer. But before new mRNA therapeutics are put to use, they need to be...

read more

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.
READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
READ MORE
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.
READ MORE