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New Accelerator℠ Process Development Service Facility Opened in Shanghai, China

June 17, 2021

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We are expanding our Accelerator process development services (PDS) capacity with a new PDS laboratory in Shanghai, China.

 

 

The new lab supports the rapidly growing biopharmaceutical market in the APAC region and together with expansions to the existing US and UK PDS laboratories, increases capacity to meet the soaring demand for process development in the biopharmaceutical industry. The opening ceremony was held at the new Pall Shanghai site on June 10, 2021 and was attended by many market leading biopharma companies and contract manufacturing organizations (CMOs).

 

 

 

Our Accelerator PDS supports biopharmaceutical customers with the development of simplified and scalable processes at an early stage, enabling them to enter clinical trials and commercialization in a timely and cost-effective manner. With this new lab, equipped with cutting-edge technologies and end-to-end solutions, our Shanghai PDS team is ready to expand their service to APAC biopharma customers providing direct access to our extensive experience in process development and scaling up, especially in cell and gene therapy.

 

 

The global cell and gene therapy market has increased at a compound annual growth rate (CAGR) of 25.5% since 2015 and is expected to grow even faster in the next five years. Amongst all the regions, the APAC’s gene therapy market, which currently accounts for 30% of the global market size, is expected to witness the fastest growth rate in the coming years. Major contributors to this growth are based in China, India and Japan. The Chinese cell and gene therapy market is forecast to register the highest CAGR from 2021 to 2026 in the APAC region, with rising funding and finance activities from the government and investors, mainly driven by cancer treatments. Since two chimeric antigen receptor (CAR)-T cell products were approved by FDA in 2017, hundreds of biotech companies have been founded in China. Notably, Fosun Kite Biotech was established in 2017 in Shanghai as a joint venture of Shanghai Fosun Pharma and US Kite Pharma, now part of Gilead Sciences, whose Tecartus is one of the FDA approved CAR-T therapies. Another joint venture between Juno and WUXi AppTec was also founded as JW Therapeutics. These organizations will be continuing to research cell and gene therapies, focusing specifically on the advancement of the cancer therapy field.

 

 

CAR-T therapy typically uses viral vectors to transduce the T cells and lentiviral vectors (LV) are commonly used due to their capability to transduce a wide variety of cells. Additionally, adeno-associated virus (AAV) and adenovirus (AV), are also widely used as viral vectors in gene therapies and oncolytic virus therapies. However, currently large-scale viral vector production remains a global challenge in terms of cost, yield, and timeline. Developing optimized and scalable processes at an early stage is critical to ensure successful commercialization.

 

 

Over the past decade the number of emerging biotech companies has been on the rise, largely due to the rapid technology innovation in cell and gene therapies and biologics. Many of the emerging organizations are virtual and semi-virtual companies, who own a promising cell and gene therapy product at lab scale but lack the expertise and resources to optimize the process and scale-up to production in order to meet patient demand. Often, a partner is needed to deliver the process development.

 

 

Many factors are critical to consider when developing a process, these include cost, robustness, scalability, risk mitigation, and regulatory compliance. With our expertise and reputation in viral vector production and scale up of AAV, LV, oncolytic virus, and other biologics, many customers choose us to be their partner for process development.

 

For more information on our Accelerator PDS please click here.

 

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Dr Benben Song

Dr Benben Song is the global product manager for services. She is globally responsible for product management of accelerator™ process development services, accelerator validation services, the accelerator documentation center and training services. Benben joined us in 2015 and has held multiple roles in leading the extractables and leachables validation studies on our products to ensure compliance with the latest regulations and evolving expectations for drug safety purpose.
Dr Benben Song is the global product manager for services. She is globally responsible for product management of accelerator™ process development services, accelerator validation services, the accelerator documentation center and training services. Benben joined us in 2015 and has held multiple roles in leading the extractables and leachables validation studies on our products to ensure compliance with the latest regulations and evolving expectations for drug safety purpose.
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