Groundbreaking experimentation in 2006 by Shinya Yamanaka (Kyoto University, Japan) led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells that are isolated and then reprogrammed into embryonic-like stem cells through the expression of a specific set of embryonic genes. Yamanaka’s discovery, which earned him the Nobel prize in 2012, enabled the use of human cells in stem cell science, bypassing the use of embryonic stem cells (ESCs). Without the ethical problems associated with ESCs, a large and diverse market for human iPSC research tools has emerged.
Axiogenesis’ current focus lies on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells, although it is expanding into new areas. Its flagship offering is its Cor.4U human cardiomyocyte product family, including cardiac fibroblasts. Cor.4U cells are used in applications for single cell analysis to high-throughput screening (HTS) in early cardiac safety and safety assessment, as well as in cardiovascular drug development.
In the neural field Axiogenesis is offering various iPSC-derived neuronal sub-types including dopaminergic neurons (Dopa.4U), peripheral neurons (Peri.4U), CNS neurons (CNS.4U) and astrocytes (Astro.4U). Sensory neurons, beta islet cells and skeletal muscle cells are in development. Axiogenesis also offers licensing of proprietary disease models, such as Hypertrophic Cardiomyopathy (HCM), and tissue models for compound screening, as well as value-added fee-for-service assays for in vitro toxicology, safety pharmacology and drug discovery.
Another well-known market leader within the iPSC sector is Cellular Dynamics International (CDI), a company which focuses on drug discovery and cell therapy. CDI was acquired by FUJIFILM Holdings Corporation in March 2015 for $307 million and has since undergone a series of internal changes. Moreover, its influence on the iPSC product market has markedly shifted as new players have entered the marketplace and secured market share. There are a few other smaller market players within the iPSC marketplace, but Axiogenesis and CDI are the clear market leaders and analysis of commercial activity over the trailing 12-to-24 months suggests that Axiogenesis may be accelerating its position.
Key Differentiators for Axiogenesis, Leading Provider of hiPSCs for Drug Discovery and Toxicology
There are a number of key differentiators that give Axiogenesis a strong position within the global marketplace for iPSC-derived cells and tissues. Ten of the top differentiators are explored below.
1. Focus on High Quality Products and Scientific Excellence
Axiogenesis has invested heavily in producing human induced pluripotent stem cell (hiPSC) products driven by scientific excellence. Unlike larger providers, Axiogenesis is flexible enough to take into account customized requests, including specific vial sizes, QC parameters, and other client requests. With scientists composing 80% of its staff, Axiogenesis specializes in providing direct support to customers.
Moreover, Axiogenesis cells are produced in state-of-the-art clean room facilities that are separated from its research and development (R&D) laboratories to provide stable and very controlled production conditions. This allows Axiogenesis the capacity to produce 1 billion cardiomyocytes per week that are QC tested for morphological, functional, and pharmacological parameters and cost-effectively priced.
2. Assays and Applications Focus
Axiogenesis differentiates itself by selling not only cells, but also complete solutions, such as validated assays. This strength has resulted from Axiogenesis’ close relationships with device manufacturers, such as Hamamatsu, Nanion, Axion, Multichannel Systems, Sophion, Molecular Devices, Acea, and others. As a result of these relationships, and the fact that Axiogenesis has most of the devices in use on a daily basis, Axiogenesis can develop assays based on these devices and iPS cells and subsequently validate them
3. Ready-to-go Protocols, with Short Culture Times
Another benefit of from having close relationships with device manufacturers is that Axiogenesis can provide ready-to-go protocols, along with cells that are optimized to meet customer needs, e.g., in terms of pre-culture times. For example, Axiogenesis’ protocol requires only 3 days for cardiomyocytes, the shortest of all commercially available iPSC-derived cardiomyocytes within the marketplace. For neurons, only 4-5 days are required before full network activity is seen. Because of the high value that researchers place on efficiency, this is a major company strength.
4. Provision of Ready-to-Use Cultured / Plated Cells
A key offering of Axiogenesis that very much enables customer efficiency is the provision of cells readily seeded onto assay plates for various commercial device platforms (MEA or impedance) or optical plates. Cells are delivered at 37°C so that customers can just “plug-and-play” and use the cells right away in their assays. This service is possible for customers across Europe and in the U.S.
5. Participation in Validations in Public Consortia
A unique attribute of Axiogenesis is that the company actively participates in validations in public consortia. The company is involved in the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative, led by the US FDA, Safety Pharmacology Society (SPS), Cardiac Safety Research Consortium (CSRC) and Health & Environmental Sciences Institute (HESI). CiPA aims to improve current regulatory guidances by introducing predictive technologies, including human stem cell-derived cardiomyocytes into preclinical cardiac safety assessment.
In the ongoing CiPA II validation study, Axiogenesis Cor.4U cells are one of only two iPSC-derived cardiomyocytes cell models that are funded by the HESI under the FDA grant. Axiogenesis is also active member of the recently formed HESI Consortium that focuses on establishing novel biomarkers that facilitate improved prediction of neurotoxic effects of drug compounds.
Finally, Axiogenesis is involved with the establishment of standards for hiPSCs in the global stem cell market through organizations such as the Standards Coordinating Body (SCB) which liaises with the National Institute of Standards and Technology (NIST), International Society for Stem Cell Research (ISSCR), and the Alliance for Regenerative Medicine (ARM).
6. Tissue and Disease Modeling Focus
Axiogenesis is unique in its focus on tissue and disease modeling. Since its inception in 2001, Axiogenesis has focused on providing relevant physiological cell solutions, making it was one of the earliest companies to develop tissue models and disease models. It filed a 2004 patent application, which has since been granted in the US, EU and Japan, on the use of stem cell derived cells in tissue and disease modeling applications.
7. 2nd Largest Global Provider for Pharma
At the time of this article, Axiogenesis is the second largest provider of iPSC-derived cell types and tissue for large pharmaceutical companies. Big pharma players are increasingly choosing Axiogenesis, because of its differentiated product portfolio, scientific excellence, and customized service. As a result of its expansion, Axiogenesis now serves a broad range of both European and American large pharmaceutical companies, including Pfizer, Boehringer Ingelheim, Abbvie, Janssen, Sanofi, the Fraunhofer Institute and many others.
8. Partner to a Broad Range of CROs
Axiogenesis has strengths within the contract research organization (CRO) segment of the marketplace. Several leading CROs have chosen to partner with Axiogenesis, and value Axiogenesis’ unbiased expert advice in positioning, setting up, validating and troubleshooting assays.
9. “Freedom to Operate” (FTO) Licenses
Axiogenesis has differentiated itself by including a commercial use label license with every sale. Through the licensing of GE Health Care (Asterias) and iPS Academia patents, Axiogenesis offers commercial use of its products in standard applications to all customers. Axiogenesis customers do not requite additional licenses from Axiogenesis, iPS academia or GEHC for the use of the cells even for commercial applications.
10. User Symposium on Defining Global Standards for Human iPSCs
Finally, Axiogenesis collaborates with members from across the stem cell community to foster and create opportunities for collaboration. Scheduled for June 13, 2016, in Boston, Massachusetts, Axiogenesis is hosting an American symposium titled, “iPSC Derived Cells & Assays Come of Age.” The event will explore the establishment of global standards for iPSC-derived cell products, a topic that is critical to a wide range of stem cell industry stakeholders, including representatives from across the pharmaceutical, biotechnology, and chemical sectors.
Axiogenesis’ Competitive Position within the Global iPSC Marketplace
To understand the competitive nature of the iPSC product market, it is important to understand both market players as well as market leaders. Already dominant within Europe and rapidly expanding stateside, Axiogenesis is looking poised for growth.
In news released May 3rd, 2016, the Axiogenesis announced a major investment from the Sino-German High-Tech Fund, which will assist Axiogenesis with expanding product development, improving its disease modeling capabilities, and growing its presence within the global marketplace. It will also accelerate the introduction of Axiogenesis products into high-yield market segments, such as the pharmaceutical and chemical sectors.
Combining the ten differentiators above with this strong financial footing, Axiogenesis has become a major player within the global iPSC marketplace. To learn more about Axiogenesis, visit www.Axiogenesis.com.
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