Axol is a market leader in large-scale manufacturing of functional iPSC-derived cells to support preclinical drug discovery.
Cells generated from induced pluripotent stem cells (iPSCs) are revolutionising in vitro modelling in drug discovery. iPSC derived cells hold the promise of being a more human relevant system to model human diseases, testing toxicity and compound screening. iPSCs are derived from adult somatic cells and reprogrammed to an embryonic-like state which, under the right conditions, can be differentiated into a specific human cell type.
Key to their greater utilisation is standardisation, scale and quality – the transition from lab-scale to large-scale iPSC manufacturing. Axol has dedicated the last decade to overcoming these challenges, providing large-scale iPSC manufacturing capabilities at our state-of-the-art facility, ensuring both quality and efficiency in the production process.
In this article, we will discuss:
- The benefits of large-scale iPSC-derived cell manufacturing
- Pre-manufactured and custom manufacturing of iPSC-derived cells
- ISSCR guidelines and quality systems utilised in our ISO:9001:2015 accredited facility
Realising Large-Scale iPSC-Derived Cell Manufacturing
As a leader in iPSC-derived cell manufacturing, Axol provides functional cells for research and drug discovery consistently and at scale. With over a decade of expertise, we understand the complexities of iPSC differentiation and the critical need for consistency. Our robust process ensures that every batch of cells meet the highest standards for functional relevance and reproducibility.
Large-scale iPSC-derived cell manufacturing refers to the production of cells in quantities that can be used for high-throughput screening services and functional models of disease. Unlike lab-scale manufacturing, which focuses on small batches for proof of concept or initial testing, large-scale iPSC-derived cell manufacturing supports rigorous quality control (QC) processes, ensuring that the cells produced are consistent, reproducible, and suitable for preclinical applications.
Our manufacturing process undergoes three rounds of technology transfer, ensuring that each batch meets stringent consistency standards. We invest heavily in QC measures, including comprehensive testing and validation and experienced scientists, to guarantee that our cells perform as expected in various cellular assays. Volumes of our cells are also used to carry out QC showing our commitment to ensuring quality iPSC-derived cells.
As we look to build in vitro models that mimic the human environment to support drug discovery programs, we recognize that existing quality control methods only characterize cells. However, we want confidence in whether they will actually perform in a model system- ultimately, will these in vitro models be useful to researchers?
At Axol Bioscience, we believe in functional quality control (fQC). This is where we challenge ourselves by saying it is not sufficient that the cells ‘look’ like the appropriate cell type but do they ‘behave’ and are they fundamentally ‘useful’ in drug discovery.
We will look to run cells within a ‘real life’ assay environment to assess performance within the model system on a batch-to-batch basis: only then will they pass fQC. This fQC data can be built into our release packages and Certificate of Analysis statements.
Examples of fQC for iPSC–derived cells
For example, our axoCells Sensory Neurons are optimized for use in advanced in vitro pain models. fQC will measure the response to capsaicin at 1μM and 10μM concentrations via multi-electrode array.
We can also build in fQC approaches for:
• axoCells Motor Neurons (measuring the appearance of synchronized burst firing via multi-electrode array) for ALS drug discovery.
• axoCells Microglia (measuring bait uptake over 24 hours against a pre-determined threshold, with inhibition when adding cytochalasin D.) for neurodegenerative disease modeling.
Pre-Manufactured vs. Custom iPSC-Derived Cells: Tailoring to Your Needs
We offer both pre-manufactured (ready-to-ship) and custom-manufactured (made-to-order) iPSC-derived cell options, providing flexibility for a wide range of research needs.
- Ready-to-Ship Cells: These pre-manufactured cell types are available immediately and are ideal for researchers who need high-quality cells without the wait. You can view these in our store now https://axolbio.com/shop/
- Made-to-Order Cells: For specific research needs, we offer custom manufacturing, tailoring production to meet your exact specifications. Whether you want to use your iPSC lines, a third-party’s, or choose from our collection, we can scale up production to accommodate small or large volumes, ensuring the availability of the right cells at the right time.
In addition to the cells themselves, we provide specialized media, supplements, and detailed protocols to support your research. These resources are available for direct use in your studies or can be integrated into our service work. We are also able to work with your lines and use your lines to carry out the service work. You can download our catalog at 2025 axoCells iPSC Catalog | Axol Bioscience to find out more.
We are highly flexible in terms of scale or production and delivery structure, and believe strongly in working collaboratively to best support your program of work.
Cell Types Available for Pre-Manufactured and Custom Orders
We offer a wide array of cell types across several categories to support a variety of research fields:
- Neuroscience: Cortical excitatory and inhibitory neurons, motor neurons, striatal neurons, microglia, astrocytes
- Ophthalmology: Retinal pigment epithelial (RPE) cells
- Cardiotoxicity Testing: CiPA-validated cardiomyocytes
- Dermatology: Sebocytes and sensory neurons
- Pain & Sensation: Sensory neurons
Showcasing Our Expertise in Microglia
Here are just a few milestones of our manufacturing performance so far with our axoCells Microglia:
- Batch runs of up to 250 x 1 million vials of live axoCells microglia
- 49 products manufactured in house
- 2023 manufacturing run QC success rate – 92%
- 100% patient donor consent and licensing
- 6 specialist cell matched media
Our ISO9001:2015 Certified Facility and ISSCR Guidelines
Our ISO:9001:2015 accredited facility adheres to the highest standards of quality management and follows the International Society for Stem Cell Research (ISSCR) guidelines to ensure compliance with the latest scientific and ethical standards.
Manufacturing iPSC-derived cells comes with its own set of challenges, including maintaining the integrity of the cells during large-scale production, controlling variability, and ensuring consistency across production runs. Our facility implements strict controls to mitigate these risks, including rigorous testing at every stage of the process. These measures, combined with continuous expert oversight, ensure that our cells meet the functional and quality benchmarks required for research.
“There is a strong history through Roslin Cells’ involvement with EBiSC (European Bank for Induced pluripotent Stem Cells) and the UK Stem Cell Bank, in the early days of developing stem cells. We are deeply rooted in compliance and quality, having been part of the consortium setting the standards for quality-controlled stem cell lines. Several of us were involved in the early foundational work for these guidelines, so we are delighted to see the publication of the Standards Document along with Axol’s continued compliance to these high standards.”
John Gardner Manufacturing Operations Manager at Axol’s Roslin site.
Given the enormous potential for human iPSCs in building more human-relevant disease models, we prioritize the consistency and quality of our products. Our Quality Management System is the bedrock for our daily work, driving quality and consistency for every one of our customers.
Our Quality Management System in brief:
- Bulk/same batch manufacturing and storage are available
- Our manufacturing facilities are ISO 9001:2015 accredited
- We conduct in-depth iPSC characterization, both pre- and post-differentiation
- Our Certificate of Analysis inserts report on the quality testing methods and result
- We provide full batch control and options of ownership
- There is full traceability of material origin and source
- We utilize a Q-Pulse Quality Management System for compliant audit-trail operation
By working with us, clients gain confidence in the reliability and reproducibility of their research. Our commitment to quality and functional relevance guarantees that every batch of cells delivered will contribute meaningfully to advancing drug discovery and therapeutic development. Whether you are seeking custom or pre-manufactured cells, we offer the scalability, expertise, and support necessary to accelerate your research with consistency and at scale.
For more information on our custom manufacturing services and pre-manufactured cells, contact operations@axolbio.com.
