Could you provide some insights into the motivation behind the expansion of GenScript's primary manufacturing facility in Zhenjiang, China, and how it aligns with the company's growth strategy in the APAC region?

In the APAC region, we have identified substantial demand for oligos in molecular diagnostics, RNAi, and gene editing, as well as a rising need for peptides in drug discovery and biomedical research. Our new manufacturing site in Zhengjiang is equipped with state-of-the-art facilities and seamlessly integrated automated workstations. This enables us to deliver large-scale, high-quality peptides and peptide libraries to the biopharmaceutical industry, particularly those focused on immunotherapy, with significantly reduced turnaround times (TAT). Additionally, we have observed a shift in the gene- and cell-therapy market from viral- to non-viral-based cell engineering due to the low immunogenicity, affordable cost, and high efficiency of the non-viral based approach. Our expanded facility is well positioned to support this industry shift by providing the necessary components, such as DNA and RNA oligos that aligned with this emerging trend.

 With the expanded oligonucleotide synthesis capability, what specific advantages does GenScript offer in terms of product range, purity levels, and capacity? How will these advancements cater to the diverse application needs in molecular diagnostics, RNAi, and genome editing?

The Zhenjiang site positions GenScript to offer better support and increase our capacity to address the emerging molecular diagnostics (MDx), RNA drug, and gene-editing markets. With this now higher capacity and faster delivery ability, we can better handle different requests from screening, in vitro and in vivo to preclinical stage for RNA drug, gene editing, or from R&D to MDx Kit materials for IVD.

GenScript can provide up to 200nt DNA & 180nt RNA oligo at kg level with up to 99% purity, 200+ and high-ratio modification is available. We can hit a capacity as high as 6,000 items/day, with an average of three days shorter delivery time, and with higher quality and consistency under CNC and clean-line management to support diverse applications. GenScript’s rigorous clean-line methodology involves strict environment control with SOP and daily monitoring to avoid exogenous contamination, and a technology process optimized to avoid cross contamination. All MDx oligo and RNA oligo is produced in a clean line environment, and we will also complete ISO 13485 validation in August 2023 at the new facility.

The microwave-assisted PepPower™ peptide synthesis platform is highlighted as a key feature of GenScript's peptide production. Can you elaborate on the advantages of this platform and how it enables GenScript to provide high-quality custom peptides and peptide libraries at industry-leading speed?

The microwave-assisted PepPower™ peptide synthesis platform is a proprietary technology developed by GenScript that enables the rapid and efficient production of high-quality custom peptides and peptide libraries.

This platform leverages the power of microwave energy to accelerate the chemical reactions involved in peptide synthesis, resulting in faster reaction times and higher yields compared to traditional peptide synthesis methods. 

Some of the advantages of the PepPower™ platform include:

• Speed: The microwave-assisted synthesis technology significantly reduces reaction times, resulting in faster production times and faster delivery of custom peptides to researchers.

• Yield: The PepPower platform also enables higher yields of peptides compared to traditional synthesis methods, resulting in more efficient use of resources and cost savings for customers.

Overall, the PepPower platform is a key feature of GenScript's peptide production capabilities, enabling the company to provide high-quality custom peptides and peptide libraries at industry-leading speed, and to help researchers accelerate their research efforts and achieve their scientific goals.

The expansion also includes large-scale peptide production capabilities and freeze-drying processes. How will these additions enhance GenScript's ability to support peptide researchers in various fields, such as drug and vaccine development, functional screening, and neoantigen discovery?

GenScript's peptide service is one of the company's key offerings, and the expansion of our primary manufacturing facility in Zhenjiang will increase the company's capacity to produce peptides at scale. The peptide library capacity has been increased up to 30,000 peptides/month. This increased capacity will enable GenScript to better serve the growing demand for synthetic peptides, which are used in a wide range of applications to support peptide researchers in various fields, such as drug and vaccine development, functional screening, and neoantigen discovery.

Considering the growing demand for oligonucleotide and peptide synthesis, how does GenScript envision its expanded facility in Zhenjiang addressing the needs of researchers and biotech companies in the APAC region? What impact do you anticipate this expansion to have on the development of innovative therapies and the overall biopharma landscape in APAC?

The increased production capacity of synthetic oligonucleotides and peptides will provide researchers in the region with faster access to critical research tools that are essential for a wide range of applications, including gene editing, gene therapy, and vaccine development. This increased access to high-quality synthetic oligonucleotides and peptides is likely to accelerate the pace of research and development in the region, potentially leading to the discovery and development of new and innovative therapies for a range of diseases.

In addition, the increased efficiency of GenScript's processes will help to reduce turnaround times and provide researchers with faster delivery of products, which can be critical for time-sensitive research projects. Furthermore, the expanded facility will enable GenScript to continue to invest in R&D and innovative technologies, which will help the company to stay at the forefront of the biopharma industry and continue to provide cutting-edge solutions to researchers in the APAC region and beyond. Overall, the expanded facility in Zhenjiang is likely to have a significant impact on the research community in the APAC region, providing researchers with access to critical research tools, accelerating the pace of research and development, and enabling the discovery and development of new and innovative therapies.

What is the importance of the new cGMP CRISPR sgRNA and NVP expansion?

Limited manufacturing capacity across the industry has created long wait times for cGMP-quality CRISPR sgRNA and HDR templates. This bottleneck threatens to delay the development of life-saving gene and cell therapies and poses a significant financial risk to the companies developing them. Expanding our manufacturing capacity, allows GenScript to offer cGMP projects without delay, and gene- and cell-therapy developers to source cGMP-quality sgRNA and non-viral DNA payloads in less time, helping them advance projects through their pipeline faster. This is critical for successful IND filing, clinical trials, and delivering the first therapy to market.

What are some of the unique advantages of GenScript’s cGMP Services?

GenScript has been providing research-grade materials to the GCT community for more than 20 years. Since 2020, we have moved into the GMP space, initially with GMP sgRNA and then followed by GMP non-viral payloads. As we offer comprehensive research-grade materials, from sgRNA to our proprietary non-viral payloads, including ssDNA, linear closed-end dsDNA, as well as now circular miniature dsDNA, we have developed an excellent customer base to move into the GMP space to further support them and provide a one-stop solution. As of April 2023, GenScript has delivered 56 batches of cGMP quality gene editing products, supporting 18 project applications, five of which have received IND approvals. This has encouraged us to expand and better meet the needs of more customers—and also shorten our TAT to help them move into clinical trials faster.