Stem Cell Synergy Solution - Manufacture

GMP-grade collagenase and neutral protease enzymes are available for gentle and efficient tissue dissociation and stem cell isolation, and offer the highest possible safety and reduced regulatory hurdles for manufacturing. Due to the stringent quality control systems in place, these enzymes are ensured to be of the highest quality and have a reliable lot-to-lot consistency. 

• GMP grade animal-free enzymes available, guarantees no risk of cross-contamination with animal-derived materials 
• High performance and reproducibility in manufacturing processes 
• Isolation of a wide range of cells, including hepatocytes, islets of Langerhans, and tumor cells
• Easy translation to GMP-grade and animal-free process, see model below:

StemFit® is a GMP grade, animal-free, chemically defined media for feeder-free culture of iPSCs and ESCs. StemFit® has over 100 fold higher expansion rate than that other culture medias. 

• Superior colony forming efficiency from a single clone
• Allows weekend-free cell culture, reducing labour costs  
• More cost-effective than competitors  
• Offers reproducible growth rates and easy transition from feeder cells
• Compatible with ABLE Bioreactor System for improved productivity, sustainability, and scalability.

iMatrix-511 is a clinical-grade recombinant laminin E8 fragment, an extracellular matrix protein crucial for cell adhesion. It is used in cell culture to efficiently expand colonies and can be combined with StemFit® Basic03 GMP cell culture media to create an ideal environment for growing PSCs for manufacturing purposes. 

• Highly purified and refined laminin E8 fragments ensuring consistent and reliable results 
• Time-saving coating-free method, reducing labour and increasing efficiency 
• Sustains long-term propagation of a wide variety of cell types, especially pluripotent cells 

Miyazaki et al (2012) showed that iMatrix Laminin-511E8 fragments demonstrate greater adhesion efficiency of dissociated cells than Matrigel or the intact Laminin-511 protein.

ABLE 3D Magnetic Stir and Disposable Bioreactor System is a 3D culture system designed specifically for the efficient and scalable cultivation of iPSC spheroid cultures. It combines magnetic stirring and disposable bioreactors to facilitate the expansion and differentiation of stem cells.

• Bioreactor capacity is 30 mL, enabling 5 to 10-fold cell expansion (up to 5 × 10⁷ cells)
• Typical growth is 200-300 μm spheroids
• Compatible with StemFit media and iMatrix-511 recombinant ECM for iPSC culture and expansion

Our StemFit Purotein ® Recombinant Proteins are a range of easy-to-use animal origin-free growth factors and cytokines which enable precise differentiation of ESCs and iPSCs into a variety of lineages including liver, pancreas, kidney, and heart cells. Available in GMP-grade formats, our StemFit Puroteins® are the superior choice for full control over differentiation during the manufacturing process. 

• High purity & performance you can rely on 
• Ready-to-use frozen formulation, eliminating the need for reconstitution and simplifying protocols
• Regulatory compliance for cell and gene therapy product manufacturing 

STEM-CELLBANKER® is the ideal solution for reliable cryopreservation of ESCs and iPSCs, as well as other delicate cell types. Available with or without DMSO, STEM-CELLBANKER® is a GMP grade cryopreservation media that ensures long-term cell storage of up to 10 years with high cell viability post-thaw. For an even more efficient workflow, STEM-CELLBANKER® EX eliminates the need for a wash step after thawing, simplifying the process before delivering a cell product.  

Our custom CELLBANKER® service allows you to tailor the formulation, volume, and container type to precisely match your manufacturing requirements. Fill out our form below for more information.

• Chemically defined and animal component free
• Maintains cell pluripotency, normal karyotype, and proliferation ability post-thaw
• Suitable for cell, tissue, and organoid cryopreservation

To hear more about how AMSBIO can help to optimise your manufacturing processes take a look at our GMP page. Here you will find our extensive range of GMP-compliant products and services designed to meet the stringent requirements of the pharmaceutical and biotechnology industries. From reagents and consumables to equipment and validation services, we offer everything you need to ensure the highest standards of quality and compliance. For a more in-depth look at GMP guidelines take a look at AMSBIO's Guide to GMP. Discover a wealth of information on GMP regulations, manufacturing practices, and quality control procedures.