How is GenScript planning to meet the growing demand for cell and gene therapies in 2023?

GenScript is committed to advancing non-viral gene and cell therapy development by providing cGMP materials that meet our partners’ demanding timelines. We achieve this by building world-class facilities and expert teams, and by maintaining an unwavering focus on service quality and on-schedule project delivery. 

We are currently expanding our cGMP sgRNA and non-viral DNA payload production capacity to maintain minimal project wait time. GenScript’s new 400,000-sq.-ft. cGMP facility in Zhenjiang, China is scheduled to open in 2023. 

What are your plans for the APAC region? 

In the near term, the APAC gene and cell therapy market is expected to experience significant growth — more than 40% through 2026 — which is faster than other major regions such as the US and Europe (BCC Research, Global Cell and Gene Therapy Market report, 2022). So, support for the APAC market is a high priority for GenScript. Although we observed the rapid rise of non-viral based GCT research in APAC (mainly in China), viral-based approaches are still the dominant technology across most of the region. Most of the biopharma companies in APAC have, or are establishing, a complete workflow for producing GMP-grade viral vectors for GCT purposes. 

GenScript is pursuing several strategies to promote the non-viral-based GCT technology:

1. Expand our capabilities in the APAC market by recently opening a new R&D and manufacturing center in Shanghai and doubling our capacity in Singapore.
1. GenScript’s new 400,000-sq.-ft. cGMP facility in Zhenjiang, China is scheduled to open in 2023.
2. In early 2022, GenScript established a 30,000-sq.-ft. protein facility in Singapore. In addition, a new 10,000-sq.-ft. gene facility with a fully automated production capability is scheduled to open in early 2023.  
2. Educate and convince regional customers of the advantages of using CRISPR-based GCT technology. 
3. Position GenScript as the leader in non-viral-based GCT technology by demonstrating our capability to provide a one-stop solution for CRISPR-based materials, from RUO to GMP grade.
4. Establish the successful use cases in the APAC region to further reinforce GenScript’s position as the leader of non-viral-based GCT. 

Which particular disease areas are you focusing on by accelerating pathways for cell and gene therapies?

Our customers are currently using CRISPR-based editing to develop potent and specific immuno-oncology cell therapies (CAR-T, NK, TCR) to treat various cancers, including T- and B-cell malignancies, multiple myeloma, melanoma, acute myeloid leukemia (AML), non-small-cell lung cancer (NSCLC), esophageal cancer, gastrointestinal cancer, and more. 

Non-viral CRISPR-based approaches are also being employed to develop novel gene therapies to treat a diverse range of single-gene disorders, including hemoglobinopathies, inherited eye disease, muscular genetic disease, genetic liver or lung disease, genetic deafness, and more. 

We aim to help accelerate the development of these therapies from research to clinic by providing high-quality cGMP sgRNA, Cas9 nuclease, and non-viral DNA payloads (ssDNA/dsDNA/circular minimized dsDNA) with fast turnaround time. 

How is the non-viral cell and gene therapies market evolving in APAC and what are the challenges associated with it?

While GenScript can support both viral and non-viral methodologies, the non-viral approach is growing much faster due to safety concerns with viral methods. An effort is, however, required to penetrate the APAC market. In contract to the United States and the European Union, GCT research using CRISPR is still relatively new in the APAC market.  Although we do see a few biopharma and biotech companies beginning to explore the potential of CRISPR for GCT purposes, researchers are still taking a wait-and-see attitude because of several challenges:  

1. Drug delivery has been a challenge for the non-viral methodologies and because of that, we have expanded our capabilities to be able to offer RNP and LNP for delivery of our CRISPR and mRNA reagents.  
2. Use of mRNA is gaining popularity as the preferred gene editing format due to its ability to eliminate concerns about long-lasting genome modifications, but production is challenging. GenScript has opened new mRNA R&D and production centers in the US to address this. In addition, by providing high-quality GMP sgRNA and non-viral payloads (ssDNA/dsDNA/circular minimized dsDNA) with fast turnaround time, we aim to help accelerate the development of these therapies, from research to clinic.  
3. Geographical differences. The level of research across the APAC region varies, resulting in the requirement of a country-specific strategy. It is essential to educate and support the fundamental GCT research with the complete GCT services that we provide.  

Bio: Dr. Ray Chen

Dr. Ray Chen is president of the Life Science Group at GenScript, the world’s top enabling platform that serves science by providing innovative, reliable, high-quality reagents and instruments. Prior to GenScript, he worked in product design in the Fabric & Home Care business unit at Procter & Gamble. Dr. Chen studied peptide chemistry at the Dr. Richard DiMarchi lab and earned his PhD in chemistry from Indiana University Bloomington, and a BS in chemistry from Nanjing University. Connect with Ray on LinkedIn.