Twist Bioscience Corporation is a synthetic biology company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology.
In fields, such as health care, food/agriculture, industrial chemicals/materials, academic research and data storage, by using the company’s products, its customers are developing ways to better lives and improve the sustainability of the planet.
The company has developed a disruptive DNA synthesis platform to industrialize the engineer...
Twist Bioscience Corporation is a synthetic biology company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology.
In fields, such as health care, food/agriculture, industrial chemicals/materials, academic research and data storage, by using the company’s products, its customers are developing ways to better lives and improve the sustainability of the planet.
The company has developed a disruptive DNA synthesis platform to industrialize the engineering of biology that provides DNA for a wide range of uses and markets. The core of the company’s platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by ‘writing’ DNA on a silicon chip. The company has miniaturized traditional chemical DNA synthesis reactions to write over 1,000,000 pieces of DNA (oligonucleotides) up to 500 bases through direct synthesis on each silicon chip, approximately the size of a large mobile phone, reducing by 99.8% the amount of chemicals the company estimate would be used per gene as compared to plate-based synthesis. The company has combined its silicon-based DNA writing technology with proprietary software, scalable commercial infrastructure and an e-commerce platform to create an integrated technology platform that enables the company to achieve high levels of quality, precision, automation, and manufacturing throughput at a significantly lower cost and quicker than the company’s competitors.
The company has applied its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next generation sequencing, or NGS, sample preparation, and antibody libraries for drug discovery and development, all designed to enable the company’s customers to conduct research more efficiently and effectively. Leveraging the company’s same platform, the company has expanded its footprint beyond DNA synthesis to manufacture synthetic RNA, as well as antibody proteins to disrupt and innovate within larger market opportunities, in addition to discovery partnerships for biologic drugs and developing completely new applications for synthetic DNA, such as digital data storage. The company sells its products to a global customer base of approximately 3,562 customers across a broad range of industries.
The company’s products enable a broad range of applications that may ultimately improve health and the sustainability of the planet across multiple industries, including healthcare for the identification, prevention, diagnosis and treatment of disease (antibody discovery and optimization technology); chemicals/materials for cost-effective and sustainable production of new and existing specialty chemicals and materials, such as spider silk, nylon, rubber, fragrances, food flavors and food additives; food/agriculture for more effective and sustainable crop production; academic research for a broad range of education and discovery applications; and technology for potential use as an alternative long-term data storage medium.
The company generates revenue through its synthetic biology and NGS tools product lines, as well as biopharma services for antibody discovery, optimization and development. In addition, the company is leveraging its platform to expand its portfolio to include other products and address additional market opportunities, including vertical market opportunities in digital data storage.
Markets
Synthetic Biology
The company’s synthetic biology products serve life sciences researchers across a variety of healthcare applications, including drug discovery, disease detection, enzyme engineering, gene editing and basic academic research. In addition, the company’s synthetic biology products are used for chemical and materials applications including development of synthetic spider silk, nylon, rubber, fragrances, flavors and food additives; for food and agricultural applications including improving crop traits such as adding vitamins or improving drought tolerance, and engineering bacteria to deliver nitrogen at the root of plants.
Next-Generation Sequencing
The company’s NGS tools play an integral role in the way the company’s customers prepare their patient samples to be sequenced. NGS has transformed many markets in recent years by changing the landscape of diagnosing disease and disorders and offers a path to prevent or treat disease. Some of the markets impacted by NGS include oncology, reproductive health, food/agriculture, consumer genomics, infectious disease research and drug discovery. As NGS technology improves and the cost of sequencing declines, new emerging markets that were once considered impractical, such as population-scale sequencing, liquid biopsy (a test that detects multiple types of cancer from a single blood sample), minimal residual disease testing and single cell sequencing, have become major areas of interest and investment.
The ability of the Twist DNA synthesis platform to precisely manufacture target enrichment probes at large scale has dramatically increased the types of projects that can now be addressed using NGS technologies. In addition to target enrichment, the company has expanded its offerings to include innovative library preparation with Twist-developed enzymes, buffers, beads, unique dual indexes (UDIs), unique molecular identifiers (UMIs), adapters and more. The company’s platform has unlocked new applications, improved data quality, and dramatically expanded the types of scientific questions that can be answered using NGS. In addition, the speed of the company’s DNA synthesis platform enables customers to quickly deploy NGS technologies to applications where the time to answer is critical.
Platform
The company developed the Twist Bioscience DNA synthesis platform to address the limitations of throughput, scalability, and cost inherent in legacy DNA synthesis methods. The company’s platform stems from extensive analyses and improvements to the existing gene synthesis and assembly workflows. The company’s core technologies combine expertise in silicon, software, fluidics, chemistry, and motion and vision control to miniaturize thousands of parallel chemical reactions on silicon and write thousands of strands of DNA in parallel.
Products
The company has developed multiple products derived from synthetic DNA and the company’s versatile DNA synthesis technology. The company’s offering consists of two primary product lines, synthetic biology tools and NGS tools, that address different needs of the company’s customers across a variety of applications. In addition to DNA, the company offers RNA and protein products.
Synthetic Biology Products
Synthetic Genes and Gene Fragments
Synthetic genes are manufactured strands of DNA. Customers (biotech, pharma, industrial chemical, agricultural companies as well as academic labs) order the company’s synthetic genes to conduct a wide range of research, including product development for therapeutics, diagnostics, chemicals/materials, food/agriculture, data storage as well as a multitude of emerging applications within academic research. Virtually all research and development of this type requires trial and error, and the company’s customers require many variations of genes to find the DNA sequence that achieves their objectives.
The company offers two primary categories of synthetic genes: clonal genes of perfect quality delivered to the customer in a vehicle called a vector; and genes that customers can place in their own vector, non-clonal genes or fragments. Within these two categories, customers can order different lengths of DNA depending on their required final gene construct. Customers can order longer genes or shorter genes and can stitch genes together to create longer or shorter constructs if desired.
The company manufactures genes of up to 5,000 base pairs in length, yielding a clonally perfect piece of DNA that the company’s customers can immediately use for their research. The company offers non-clonal genes of up to 5,000 base pairs in length, which addresses the vast majority of demand for non-clonal genes. The company also offers larger quantities of DNA for customers who require it for their development efforts. The company’s error rate for gene fragments is 1:7500 nucleotides.
In November 2023, the company introduced Express Genes, a product line that offers customers the same perfect-quality clonal genes at a turnaround time of 5 business days. The company charges a premium for this fast turnaround time. The company makes all genes and gene fragments on the company’s Express timeline.
In fiscal year 2024, the company expanded its Express product portfolio to include many other products offered including Multiplexed Gene Fragments on a fast turnaround timeline. The company’s ability to provide this rapid turnaround for products at scale differentiates the company from its competitors.
Oligonucleotide, or Oligo Pools
Oligo pools, or high diversity collections of oligonucleotides, are utilized in many applications, including targeted NGS, CRISPR gene editing, mutagenesis experiments, DNA origami (the nanoscale folding of DNA to create two- and three-dimensional shapes at the nanoscale), DNA computing and data storage in DNA, among others. The company’s oligo pools are also used for high-throughput reporter assays that are used to study cell signaling pathways, gene regulation, and the structure of cell regulatory elements. For these applications, the company provides customers with accurate and uniform synthetic oligos to precisely match their required designs.
The company sells a diverse, customizable set of oligo pools, ranging from a few hundred oligos to over one million, and offer oligonucleotides of up to 500 nucleotides in length, with an error rate of 1:3000 nucleotides. In fiscal year 2024, the company added an offering of cloned oligo pools to further enable researchers.
IgG Proteins
Pairing the automation in the company’s synthetic biology platform along with its expertise in antibody discovery, the company introduced an immunoglobulin G (IgG) protein offering for the company’s customers focused on the pursuit of drug discovery and development. In the process of antibody discovery, antibody fragments (Fab, small chain fragment variable (scFv) or VHH) must be reformatted to full IgGs. Leveraging the company’s silicon-based synthesis platform, the company provides customers with a high throughput IgG capability, removing this bottleneck from the antibody discovery process. The company offers standard and Express turnaround times in both CHO and HEK293 cell lines.
NGS Tools
Building from the company’s DNA synthesis platform, the company has developed products to enable next-generation sequencing. The company’s products work on multiple sequencing platforms as the company is sequencer agnostic. In particular, the company is focused on addressing the demand for better sample preparation products that improve sequencing workflow, increase sequencing accuracy, and reduce downstream sequencing costs. Using the company’s silicon-based DNA synthesis platform, the company is able to synthesize exact sequences of interest. In the target enrichment process, the company’s synthetic DNA probes bind to the sequence of interest within the sample, acting like a magnet to isolate and physically extract the targeted segment of DNA.
The company’s NGS products are primarily used within diagnostic tests for various indications including rare disease, SARS-CoV-2 and cancer through liquid biopsy and minimal residual disease (MRD). In addition, customers use the company’s NGS tools for population genetics research and biomarker discovery, translational research, microbiology and applied markets research. The company’s customers are primarily diagnostic companies and hospitals, research institutions, agricultural biotechnology companies, and consumer genetics companies conducting diagnostic tests for a wide range of applications.
In the fiscal year ended September 30, 2024 (fiscal year 2024), the company added several innovative library preparation products for specific applications, leveraging the company’s unique ability to develop proprietary enzymes for use within the workflows.
The company offers a wide variety of NGS tools for its customers including library preparation kits, human exome kits, fixed and custom panels as well as Alliance panels. Alliance panels are customer-curated content sold through Twist. In addition, the company offers specific workflow solutions including a methylation detection kit for cancer, rare and inherited disease study, as well as a fast hybridization solution (FastHyb), which allows researchers to go from sample to sequencer in a single day. In addition to NGS tools for DNA workflows, the company offers full RNA sequencing workflows.
Synthetic controls
Leveraging the company’s DNA synthesis platform, the company offers positive synthetic controls that provide quality control measures for a wide range of applications from assay development to routine testing of samples with both next-generation sequencing (NGS) and reverse transcription polymerase chain reaction (RT-PCR) assays.
Drug and Target Discovery Solutions
Precision DNA Libraries
The company’s platform allows customers to customize every antibody sequence variation and construct a precise library systematically to target the entire region of interest. The company can create single-site libraries in which the company changes a single amino acid (which is encoded by a group of three DNA nucleobases) within the sequence or single-site saturation libraries in which the company changes every amino acid within the sequence for a more comprehensive approach. The company can also generate combinatorial libraries in which the company introduce changes to multiple sites within the same gene in specific ratios and combinations. These libraries can be used for antibody engineering, affinity maturation, and humanization, which simplifies downstream screening and identifies more lead molecules. The company’s libraries are explicitly developed for a specific area of the genome or tailored to a specific disease, with antibody compounds evenly represented across all desired areas of the genome.
Biopharma Services
The company’s biopharma services group offers the ‘discovery trifecta’ – in vivo, in vitro and in silico antibody discovery all under one roof. The company provides comprehensive discovery services for the company’s partners that results in improved diversity, improved screening, ultra fast lead selection and engineering, which can mean a faster path in the race to the clinic.
Partnerships with Leading Companies
The company has several avenues available to monetize the company’s antibody discovery program. In general, partnerships for the company’s antibody development platform require the company to provide rapid, on-demand (high affinity) antibodies based on one or more targets provided by the customer.
Customers can design and purchase libraries, and the company works with partners that bring the company a target, to discover antibody leads against that target. These partnerships generate revenue in up-front fees, through the license of libraries and service revenue. In addition, many of the company’s partnerships include success-based milestones for key clinical, regulatory and commercial achievements and/or royalties on any product sales resulting from the company’s collaboration.
As of September 30, 2024, the company generated antibody leads to multiple biological targets and these antibody leads are in various stages of early discovery and development.
As of September 30, 2024, the company had signed 365 revenue-generating partnerships. Through these partnerships, the company had 955 completed programs and 89 active programs with 73 of the programs including milestones and/or royalties as of September 30, 2024. Some of the company’s partners include Bayer, Boehringer Ingelheim GmbH, Takeda Pharmaceutical Company Limited, Adicet Bio, Ono Pharmaceutical Ltd., Kyowa Kirin, Invetx, Inc., Astellas Pharma Inc. and Neogene Therapeutics, Inc.
In October 2024, the company entered into an agreement with XOMA Royalty. The company retains all upfront, service and other revenue earned under antibody discovery and biopharma solutions agreements, as well as half of future milestones and royalties.
Growth Strategy
The company’s strategies are to maintain and expand the company’s position as the provider of choice for high-quality, affordable synthetic DNA, RNA and proteins to customers across multiple industries; become a leading supplier of NGS sample preparation products; conduct biopharma services for the company’s current customers and future partners; continue to develop commercial solution for storing digital data in DNA; and expand the company’s global presence.
Beyond these opportunities, the company is working with industry partners to create new markets for the company’s products by leveraging the company’s platform.
Sales and Marketing
The company has built a versatile and scalable commercial platform that enables the company to reach a diverse customer base that the company estimates consists of over 100,000 synthetic DNA users, potential customers of the company’s NGS tools products and partners who may use the company’s services for antibody discovery. In order to address this diverse customer base, the company employs a multi-channel strategy consisted of a direct sales force targeting synthetic DNA customers, a direct sales force focusing on the NGS market and an e-commerce platform that serves both commercial channels. The company employs business development and sales representatives for the company’s biopharma solutions as well. The company’s sales force is focused on customer acquisition, support, and management across industries, and is highly trained on both the technical aspects of the company’s platform and how the company’s product and services can be used in a wide range of industries. The company’s easy-to-use e-commerce platform allows customers to design, validate, and place on-demand orders of customized DNA online, and enables them to receive real-time customized quotes for their products and track their order status through the manufacturing and delivery process. This is a critical part of the company’s strategy to address the company’s large markets and diverse customer base, as well as drive commercial productivity, enhance the customer experience, and promote loyalty.
The company sells its products through a worldwide commercial organization that includes direct sales personnel, commercial consultants in Europe and Asia, an e-commerce platform and distributors.
Patents and Other Intellectual Property Rights
Worldwide, the company owns or exclusively in-licenses over 150 issued or allowed patents and more than 250 pending patent applications as of September 30, 2024. In addition to these owned and exclusively licensed patents and pending patent applications, the company licenses patents on a non-exclusive and/or territory restricted basis. The company’s intellectual property portfolio includes important patents and patent applications directed to DNA synthesis, next generation sequencing, antibody libraries, and DNA data storage.
Competition
The company faces competition from a broad range of providers of synthetic biology products such as GenScript Biotech Corporation, DNA Script, Inc., GENEWIZ (owned by Azenta), Integrated DNA Technologies, Inc. (owned by Danaher Corporation), DNA 2.0 Inc. d/b/a/ ATUM, GeneArt (owned by Thermo Fisher Scientific Inc.), Eurofins Genomics LLC, Promega Corporation, OriGene Technologies, Inc., Blue Heron Biotech, LLC, Elegen and others. Additionally, the company competes with both large and emerging providers in the life sciences tools and diagnostics industries focused on sample preparation for NGS such as Thermo Fisher Scientific Inc., Illumina, Inc., Integrated DNA Technologies, Inc., Roche, New England Biolabs and Agilent. In the antibody discovery market, the company competes with contract research organizations including Curia, GenScript, and Genovac (formerly part of Aldevron, LLC), and antibody discovery biotechnology companies, such as Fair Journey/Iontas, Adimab, Distributed Bio (owned by Charles River), Ablexis, Specifica, OmniAb and AbCellera Biologics Inc. In the emerging field of DNA digital data storage, the company competes with Biomemory, Catalog Technologies, Inc., GenScript, various academic institutions, and other emerging competitors.
Government Regulation
The company is a leading provider of synthetic DNA products, serving customers across research, development, and commercial applications. The company offers a wide range of products intended for ‘Research Use Only’ (RUO) as well as a limited catalog of NGS tools that have been CE-marked pursuant to, and regulated by, the In Vitro Diagnostic Device Regulation (EU) 2017/746, or IVDR, and sold as in-vitro diagnostic medical devices (IVDs) in the European market. The company’s RUO products are sold and promoted for non-diagnostic and non-clinical purposes to academic institutions, life sciences and research laboratories, and biopharmaceutical and biotechnology companies who then integrate the company’s products into their workflows for further commercialization. These products serve as vital research tools, enabling the company’s customers to develop a diverse spectrum of commercial products.
Aside from certain labeling requirements, most of the company’s products, as marketed, are largely unregulated by governmental bodies, including the FDA.
The company has been recently evaluated by an external third party who has determined that the company has processes in place to support compliance with current Good Manufacturing Practices (cGMP) and to support the required regulatory requirements as future regulations are updated by the FDA. The company’s quality management system adheres to ISO 13485:2016 to ensure the quality and reliability of the company’s products.
The company launched a limited line of IVDs that are CE-marked and IVDR compliant to support the company’s European customers who are in the in vitro diagnostic medical device market.
In February 2024, the company introduced IVDR-compliant Precision Dx products for whole exome sequencing to meet the needs of the company’s European customers and demonstrate the company’s commitment to providing compliant solutions for clinical and diagnostic use in the EU.
Research and Development
The company's research and development expenses were $90.9 million for the year ended September 30, 2024.
History
Twist Bioscience Corporation was founded in 2013. The company was incorporated in the state of Delaware in 2013.
