Despite the anticipated approvals of 16 new cell or gene therapies in 2023, the development of Cell and Gene Therapy (CGT) continues to face hurdles, including technological limitations, undeveloped capacity, and commercialization. However, the industry remains steadfast in its efforts to overcome these bottlenecks.

 

Among so many efforts to propel progress forward, what sets WuXi Advanced Therapies (ATU) apart is its comprehensive testing capabilities and unique business model. As a Contract Testing Development and Manufacturing Organization (CTDMO) with global operations, WuXi ATU offers integrated, end-to-end solutions that allow all assay development, biosafety, viral clearance and product release testing to be completed in-house, helping expedite the R&D process of advanced therapies.

 

"In the CGT industry, analytical and release capabilities deeply affect the development process of innovative therapies and the safety and effectiveness of final products. WuXi ATU owns a comprehensive in-house testing system, which is one of our core technical advantages,” said Dr. Angela Chen, Chief Business Officer of WuXi ATU.

 

In addition, the transformational technology platforms hold the potential to shape the future of the CGT R&D process. To make the treatments more cost-effective and reliable for the large population of patients, WuXi ATU has been embarking on automation and manufacturing unit operation integration, particularly adopted in the realm of cell therapy.

 

Furthermore, WuXi ATU will continue to enhance its capacity and capabilities to address the bottleneck associated with large-scale viral vector manufacturing. The state-of-the-art technology, known as TESSA™ (Tet Enabled Self Silencing Adenovirus), has significantly increased productivity of AAV (adeno-associated virus) vectors by 30-40 times compared to plasmid-based manufacture, reaching over 95% full capsid. The AAV process development can be completed within 12 months from DNA to IND, with the potential to be scaled up to 2000L. This could open the door to treating more patients in a more cost-effective way. Additionally, our Lenti Stable cell line can grow at any desired scale, and then induce LVV production.

 

In response to the growing demands of partners, WuXi ATU expanded its global presence with sites across the US, UK, China, and recently Singapore. David Chang, President and CTO of WuXi ATU, said “Each site plays a unique role, and they work together to provide customers with fully integrated and synergized services, accelerating the R&D of cell and gene therapy and ultimately making a meaningful impact for patients across the globe.”

 

Recently, WuXi ATU and T-MAXIMUM signed a strategic collaboration agreement. WuXi ATU will provide integrated testing, development and manufacturing and IND filing services for T-MAXIMUM's UCAR-T product. By exploring cutting-edge technologies, WuXi ATU helps partners lower the barriers of R&D and expedite the discovery and development of new medicines for patients globally.

 

Looking forward, 2023 is a year of significance for WuXi ATU, as we have two commercial products from two different clients undergoing regulatory inspections and approvals. One product is a viral vector, and the other is a cell therapy product. This marks a significant leap for WuXi ATU, as we move from being a clinical supplier to a commercial one. As cell and gene therapy continues to evolve and transcend existing barriers, WuXi ATU remains dedicated to unlocking its full potential and paving the way towards a future where "a single treatment, a permanent cure" becomes a reality for all patients.

 

About WuXi Advanced Therapies (WuXi ATU)

 

As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information, please visit https://www.advancedtherapies.com