Successful clinical applications of regenerative medicine require consistent, reliable, and scalable solutions - which is why we are constantly innovating with purpose to help you to:
- Minimize variability
- Ensure a robust compliance strategy
- Incorporate scalability from the outset
- Enhance the efficiency of your workflow
From GMP products to flexible analytical instrumentation, we can equip you with the tools you need to forge a pathway to safe, effective, and scalable therapies. Seamlessly transition from RUO to GMP manufacturing with our support, ensuring compliance and continuity.
Regenerative Medicine Workflow
Cell Isolation and Culture
The types of cell sources used in regenerative medicine can be highly variable, including dermal fibroblasts, blood cells, and stem cells. Processing these cells with high throughput and accuracy can be time-consuming and variable, especially if it's necessary to isolate and maintain high yields of rare cell types from vast populations. Ensure minimal variability and the overall health of your stem cells using our consistent and effective techniques.
Boosting Stem Cell Quality
A robust and healthy starting cell population is crucial for successful stem cell preparation as this impacts subsequent expansion and differentiation efficiency. Our portfolio of premium flow cytometry and custom GMP antibodies ensures highly pure stem cell populations, laying the foundation for excellence in your research and manufacturing.
Establish Clonal Stem Cells
The Namocell Single Cell Dispensers, Hana™ and Pala™ combine flow cytometry, microfluidics, and liquid-dispensing technologies into a cartridge-based system, enabling fast and gentle sorting of single stem cells while preserving cell integrity and viability.
Select the Right Clones
Confirm that you have the right clone of interest by analyzing protein expression and purity with CE-SDS on the Maurice™ system. The Maurice system’s Turbo CE-SDS™ cartridge enables rapid, high throughput, and high-quality analysis, getting you protein size data in as little as 5.5 minutes per sample. The CE-SDS PLUS™ cartridge gives you even higher resolution, for further downstream characterization and QC.
The properties of a starting cell culture can significantly vary depending on the composition of the culture medium, making it essential to minimize variations between batches. Opting for serum-free or animal-free cell cultures can effectively reduce variability and simplify compliance.
Reprogramming to iPSCs
Reprogramming easily accessible somatic cell types to generate induced pluripotent stem cells (iPSCs) has opened up the possibility of groundbreaking regenerative medicines. However, challenges like reprogramming efficiency, mutation risk, and exogenous gene reintroduction hinder translation to clinical applications. Enhance your efficiency, cell viability, and throughput using our innovative techniques.
Regulatory Compliant Reprogramming Solutions
Small molecules, used as ancillary materials in the generation of stem cell therapies, are required to be safe and reliable to ensure the safety of the therapeutic. Our GMP products are manufactured to ISO 9001 certifications, USP and European guidelines, guaranteeing consistent and quality-assured ancillary materials.
Unravel the Stem Cell Signaling Web
Quantify changes in intracellular signaling pathways during reprogramming with Simple Western systems. Experience unrivalled multiplex flexibility, sensitivity and reproducibility in measuring protein expression, with analysis that scales to manufacturing workflows.
Efficient Verification for Reliable Results
Reduce variation and enhance consistency between studies by verifying a healthy starting cell population with our PSC Functional Identification Kit. Provides results in just five days, saving time and reagents.
- Web: Induced Pluripotent Stem Cells
- Product Guide: Small Molecules in Stem Cell Research
- Application Note: Unraveling the Signaling Web in Stem Cells with Simple Western
Engineering novel cells has never been easier - from efficient large DNA payload delivery to automated single cell isolation and analysis. We've been hard at work to develop a range of solutions that not only save your precious time but also pave the way for effortless scalability.
Simplified Cell Engineering
Rapidly generate transgenic cells for proof-of-concept studies through to scale up with TcBuster™, a cutting-edge transposon-based gene delivery platform. With its high editing efficiency and large cargo capacity, TcBuster provides unparalleled flexibility and ease in cell engineering, especially for iPSCs.
Characterization Made Easy
Ensure optimal clonality with Namocell Single Single Cell Dispensers. Thanks to exceptional efficiency and consistency in isolating individual cells, single cell cloning is simple and fast, enabling full characterization of desired clone phenotypes and genotypes.
Steamline Protein Expression Quantification
Simple Western systems streamline protein expression quantification post-cell engineering. Offering precise measurements, these automated capillary-based immunoassays enable simultaneous detection of total proteins without the need for housekeeping proteins, in sample sizes as low as 3 μL.
- Video: TcBuster Non-Viral Gene Delivery
- Article: Accelerating Cell Therapy Discovery & Development with Non-Viral Gene Engineering
- Web: Analytical Solutions for Cell and Gene Therapy
Regenerative medicine therapies need a significant quantity of high-quality stem cells, making large-scale expansion a critical step. The success of this stage depends on three crucial factors: scalability, consistency, and the preservation of differentiation potential in stem cells. This requires cell culture conditions that are not only optimized and consistent, but also specifically tailored, to efficiently expand stem cell populations while preserving essential characteristics following differentiation.
Animal-Free PSC Culturing
Achieve robust expansion and consistent maintenance of pluripotent stem cell cultures with ExCellerate™ iPSC Expansion Media. Compatible with various matrices and cell lines, it sustains cell viability, genotype, and differentiation potential. Free of animal components and available in both RUO and GMP formulations, it offers optimized buffering for reliable and reproducible results.
Animal-Free RUO and GMP Proteins
Cytokines and other growth factors play an essential role in cell expansion, health and function. Enhance the safety, bioactivity, and consistency of your stem cell cultures by harnessing high-quality, animal-free GMP growth factors and cytokines.
Extracellular matrices play a crucial role in supporting stem cell growth and organoid culture. Our diverse selection of Cultrex™ extracellular matrices are carefully designed and optimized for specialized 2D and 3D applications, ensuring lot-to-lot consistency, minimal endotoxin levels, and consistent protein concentration and composition.
When it comes to ensuring the reliability, consistency, and precision of your cell line differentiations, as well as the traceability and compliance of your raw materials, where do you begin? The answer lies in partnering with a dependable supplier who can guarantee these critical factors. Not only do we provide a steady stream of high quality, qualified reagents but we also produce 90% of our products in-house, ensuring uninterrupted access to the right materials when you need them.
Tunable Cell Culture
Experience chemical reprogramming, targeted differentiation, and enhanced cryopreservation viability using our GMP Small Molecules. With a steadfast commitment to consistency, safety, and traceability, we provide high levels of bioactivity and minimal batch-to-batch variability.
One Tool for Complete Verification
Streamline your stem cell differentiation with our all-in-one StemXVivo® Differentiation Kits. Complete with growth factors, small molecules, and cell marker antibodies, these kits provide straightforward and validated procedures for inducing and verifying stem cell differentiation status.
Enhanced Stem Cell Analysis
Flow cytometry is a powerful method for comprehensive characterization, analysis, and isolation of stem cells and their derivatives. We provide a diverse range of antibodies, reagents, and tools to streamline and optimize your flow cytometry experiments, enabling you to investigate large cell populations at the single-cell level.
Gaining accurate, quantitative insight into stem cell differentiation signaling networks is essential yet challenging. Simple Western systems provide high throughput, flexible multiplexing, and unprecedented sensitivity and reproducibility for a complete understanding of stem cell biology.
Final Product Characterization
Ensuring successful scale-up of cell products requires your product to meet all critical quality attributes (CQAs), encompassing safety, identity, purity, and potency. Our customizable, flexible, and automated assay and analytical systems take into account the precise demands of your cell samples to provide you with the solutions you need.
Automated Protein Analysis
Fully quantify protein expression with our advanced Simple Western systems - specially designed to handle complex sample types like whole-cell lysates and tissue homogenates. High-throughput sample processing and automated protein analysis allow you to accelerate your journey from benchtop to clinic.
Gold Standard ELISA Kits
For secretion profile quantitation and potency testing, Quantikine™ ELISA kits are the gold standard, providing exceptional sensitivity with 90-minute QuicKit options. Trusted across multiple industries, our kits are master calibrated for superior quality and reproducibility.
Rapid Purity Assays
Ella™, an automated ELISA platform, delivers consistent, reproducible results in under 90 minutes, with limited manual steps. Featuring high sensitivity and 200+ target analytes, Ella is ideal for accurate purity assays, including the detection of residual viral vectors, growth factors, and cytokines.
In Vivo Monitoring
Cell-based therapies aim to restore damaged tissue by introducing functional cells that engraft with native cells, facilitating organ function recovery. However, monitoring and analyzing these cells, in addition to host immune responses, requires highly sensitive techniques capable of investigating large cell populations at the single-cell level. Achieve optimal therapeutic understanding and outcomes with our tailored, pioneering solutions.
Accurately assess treatment efficacy with our RNAscope ISH technology. Clearly differentiate between therapeutic cells and endogenous cells with powerful spatial genomic and transcriptomic tools for the analysis of tissue biodistribution at a single-molecule resolution.
Rapid Immune Response Measurement
Rapidly and accurately measure the host immune response with Luminex assays by quantifying cytokine release. With bead-based multiplexing, these assays allow simultaneous analysis of up to 50 targets in a single sample, saving you time and sample volume.
Successful Research-to-Clinic Translation Using Industry-Leading Raw Materials
Having the right quality grade materials at every stage, from development to manufacture can significantly streamline your workflow and shorten your time to clinic. We work with you to:
Minimize Supply Chain Obstacles
Our cutting-edge 61,000 sq ft animal-free GMP manufacturing facility is designed to accelerate your regenerative therapy development with a constant supply of the right materials at the right time. Our expert team takes your preclinical success seamlessly into clinical development.
Futureproof Your Clinical Program
Making an early investment in GMP-grade raw materials can help futureproof your clinical programs. With GMP products that are directly comparable to our RUO animal free versions, we can ensure a smooth transition from RUO to GMP manufacturing, avoiding potential regulatory roadblocks.
Utilize High-Quality Custom Reagents
We understand the uniqueness of each stem cell-based therapy. If you can't find what you need, our custom services can develop GMP and RUO grade products tailored to your specific requirements, making your workflow simpler.