GMP-Compliant Products & Services
Explore our range of high quality, GMP-compliant Products & Services to streamline your clinical translation.
Good Manufacturing Practice (GMP) is a system which ensures that products are consistently manufactured to a high quality, and are important guidelines for the manufacture of Advanced Therapy Medicinal Products (ATMPs).
AMSBIO is an ISO 9001 registered firm and we understand the importance of GMP compliance in Regenerative Medicine research.
We offer a range of GMP-compliant products with guaranteed quality and consistency for your pre-clinical and clinical ATMP research.
Disclaimer: AMSBIO's GMP-compliant Products & Services are not pharmaceuticals/therapeutic products, and are only intended for manufacture of investigational ATMPs. They are not suitable for direct administration to humans.
Benefits of GMP-compliant products from AMSBIO
- Secure supply of reliable, high quality, GMP-compliant ancillary materials for your ATMP research.
- Streamlined pre-clinical to clinical translation.
- Confidence in your supply chain - AMSBIO is ISO 9001 certified.
- FDA-registered Drug Master Files available.
- ICH* stability studies support enzyme storage and shipping conditions.
- Ensured traceability - all required documentation available upon request.
* ICH = The International Council for Harmonisation
Cell Culture Media
Cell culture media is a vital ancillary material for the development of cell therapies, and our StemFit® medium offers superior maintenance and colony expansion of pluripotent stem cells (iPSCs and ESCs).
StemFit® Basic 03 GMP-grade
Developed in collaboration with Nobel-prize winning scientist Prof. Shinya Yamanaka, StemFit® Basic 03 is an animal-origin free, chemically-defined and clinically relevant medium available in a GMP-compliant formulation, ideal for pre-clinical and clinical research.
- Guaranteed quality & safety - StemFit® Basic 03 GMP-grade is manufactured under GMP guidelines by a certified ISO 13485 facility in the U.S.
- Avoid regulatory delays by using animal-origin free and clinically relevant cell culture media early in your ATMP research.
- Confirmed by the PMDA in Japan to be eligible for use in cell therapy.
- Superior performance compared to other commercially available medias.
*Japan equivalent to FDA.
|StemFit® Basic03 - GMP Grade Stem Cell Culture Media||Liquid A:400 ml/Liquid B:100 ml||View|
Directed differentiation of pluripotent stem cells into a variety of specialized tissue types is stimulated by the addition of recombinant proteins to cell culture media. Our GMP-grade StemFit Purotein® options are ideal for the development of differentiated cell types for ATMPs. StemFit Puroteins® are also highly compatible with our StemFit® medium!
StemFit Purotein® Recombinant Proteins
StemFit Purotein® Activin A and bFGF recombinant proteins are manufactured to GMP guidelines and have been approved by the PMDA* in Japan for ATMP manufacture.
bFGF is a growth factor used in the expansion of iPS/ES cells, and both bFGF and Activin A are used to direct the differentiation of iPS/ES cells towards cells of the liver, pancreas, or kidney.
- Animal-origin free.
- High purity and performance.
- Highly compatible with StemFit® Basic 03 cell culture media.
- Reliable lot-to-lot consistency.
- Ready-to-use frozen formulation, simplifying your protocols & reducing the risk of bacterial contamination.
High-viability and streamlined cryopreservation of stem cells for storage and shipping is crucial for the successful commercialization of ATMPs. AMSBIO offers a wide range of GMP-grade cryopreservation solutions suitable for pre-clinical and clinical applications.
A chemically-defined, animal-free stem cell cryopreservation solution manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines.
- Clinically relevant - contains only European or US Pharmacopoeia graded ingredients.
- Optimized for storage of ES/iPSCs and other fragile cell types, it is an optimal choice for storage of cells developed for cell therapy applications.
- Drug Master File registered with the FDA, for a streamlined clinical translation.
GMP-grade STEM-CELLBANKER® is also available in a DMSO-free formulation, for clinical applications where DMSO is an unsuitable freezing agent.
Expanding the possibilities of cell therapy, STEM-CELLBANKER® EX is a GMP-compliant, chemically defined, sterile, & xeno-free cryopreservation media you can rely on for safe & easy storage of your ATMP.
- Composed of ingredients that are already approved in the manufacture of cell therapy excipients for intravenous injection.
- Optimized for applications in regenerative medicine: no requirement for washing of the cryopreservation solution upon delivery of the cell therapy product.
- Drug Master File registered with the FDA - CBER.
HSC-BANKER® is a GMP-compliant cryopreservation solution optimised for hematopoietic stem cells. Its simple formulation offers the potential to be used as an excipient in cell therapy applications.
A study by the Cord Blood Bank of the Japanese Red Cross Society found that HSC-BANKER can effectively replace conventional 8% DMSO and DEXTRAN-containing media for cryoprotection of HSCs. View results here.
Find out more about HSC-BANKER here.
|HSC-BANKER - GMP Grade (formerly 11900)||15 ml||View|
|STEM-CELLBANKER - GMP Grade (100ml) (formerly 11890)||100 ml||View|
|STEM-CELLBANKER - GMP Grade (20ml) (formerly 11897)||20 ml||View|
|STEM-CELLBANKER - GMP Grade (4 x 20 ml)||4 x 20 ml||View|
|STEM-CELLBANKER DMSO FREE - GMP Grade (100ml) (formerly 11890F)||100 ml||View|
|STEM-CELLBANKER DMSO FREE - GMP Grade (20ml) (formerly 11897F)||20 ml||View|
|STEM-CELLBANKER DMSO FREE - GMP Grade (4 x 20 ml)||4 x 20 ml||View|
|STEM-CELLBANKER EX - GMP Grade (100ml) (formerly 11890EX)||100 ml||View|
Efficient and reliable cell detachment and tissue dissociation using enzymes is crucial for cell viability and successful downstream applications of the dissociated cells. Therefore, dissociation enzymes are key ancillary materials in ATMP development.
In partnership with Nordmark Pharma GmbH, AMSBIO provides superior GMP-compliant Collagenase and Neutral Protease with high quality and reliable lot-to-lot consistency, for your ATMP research.
- Optimal for applications with GMP requirements e.g. tissue engineering and cell therapy.
- Superior quality enzymes with reliable lot-to-lot consistency for your ATMP research.
- Cost effective - Research-Grade formats with equivalent enzymatic activities are available for protocol optimisation.
- ICH stability studies* support storage and shipping at room temperature (+2 to +8 °C) without compromised activity or quality.
- Animal-origin free enzymes are available, for the highest possible safety standard.
- All required documentation is available upon request.
*ongoing ICH study for N0003855.
Collagenase and Neutral Protease NB
GMP-compliant Collagenase and Neutral Protease NB are an optimal solution for isolation and passaging of a broad range of cells dedicated for tissue engineering and transplantation into humans.
High Safety Standards:
- TSE (transmissible spongiform encephalopathy) safety of the fermentation product is certified by the EDMQ.**
- Endotoxin tested.
- ICH stability & virus validation studies.
** fermentation medium for Collagenase and Neutral protease NB production contains raw materials of bovine origin. EDMQ = European Directorate for the Quality of Medicines & Healthcare.
|Research-Grade format||GMP-Grade format|
Collagenase NB4 Standard Grade & Collagenase NB5 Sterile Grade
|Collagenase NB6 GMP Grade|
|Collagenase NB1 Premium Grade||Collagenase NB1 GMP Grade - (Animal-Free format available)|
Neutral Protease NB
|Neutral Protease GMP Grade - (Animal-Free format available)|
Animal-free Collagenase and Neutral Protease
Nordmark AF enzyme manufacturing process is completely free of any animal-based components, ruling out TSE concerns and reducing the risk of regulatory hurdles.
Instead, Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade are derived from a fermentation process using a plant-based medium, providing the highest level of safety!
Our AF enzymes are highly active and designed to effectively isolate very sensitive cells from tissues such as liver, pancreas, and solid tumours.
|Collagenase AF-1 GMP Grade||>=150 U (PZ)||View|
|Collagenase AF-1 GMP Grade||>=2000 U (PZ)||View|
|Collagenase NB 1 GMP Grade||>=2000 U (PZ)||View|
|Collagenase NB 6 GMP Grade||1 g||View|
|Collagenase NB 6 GMP Grade||100 mg||View|
|Neutral Protease AF GMP Grade||>=100 U (DMC)||View|
|Neutral Protease NB GMP Grade||>=100 U (DMC)||View|
Cell response analysis in SARS-CoV-2 infected bronchial organoids.
Sano, E., Suzuki, T., Hashimoto, R., Itoh, Y., Sakamoto, A., Sakai, Y., . . . Takayama, K. (2022). Communications Biology, 5(1), 516.
A protocol to differentiate nociceptors, mechanoreceptors, and proprioceptors from human pluripotent stem cells.
Saito-Diaz, K., & Zeltner, N. (2022). STAR Protocols, 3(2), 101187.
Establishment of Organoids From Human Epithelioid Sarcoma With the Air-Liquid Interface Organoid Cultures.
Wakamatsu, T., Ogawa, H., Yoshida, K., Matsuoka, Y., Shizuma, K., Imura, Y., . . . Takenaka, S. (2022). Front Oncol, 12, 893592.
Phenotyping clonal populations of glioma stem cell reveals a high degree of plasticity in response to changes of microenvironment.
Innes, J. A., Lowe, A. S., Fonseca, R., Aley, N., El-Hassan, T., Constantinou, M., . . . Brandner, S. (2022). Laboratory Investigation, 102(2), 172-184.
Inflation-collapse dynamics drive patterning and morphogenesis in intestinal organoids.
Tallapragada, N. P., Cambra, H. M., Wald, T., Keough Jalbert, S., Abraham, D. M., Klein, O. D., & Klein, A. M. (2021). Cell Stem Cell, 28(9), 1516-1532.e1514.
On-chip 3D neuromuscular model for drug screening and precision medicine in neuromuscular disease.
Osaki, T., Uzel, S. G. M., & Kamm, R. D. (2020). Nature Protocols, 15(2), 421-449.
Xeno-Free Reprogramming of Peripheral Blood Mononuclear Erythroblasts on Laminin-521.
Skorik, C., Mullin, N. K., Shi, M., Zhang, Y., Hunter, P., Tang, Y., . . . Schlaeger, T. M. (2020). Current Protocols in Stem Cell Biology, 52(1), e103.
Cardiac hypertrophy in a dish: a human stem cell based model.
Johansson, M., Ulfenborg, B., Andersson, C. X., Heydarkhan-Hagvall, S., Jeppsson, A., Sartipy, P., & Synnergren, J. (2020). Biology Open, 9(9), bio052381.
Longitudinal single-cell RNA-seq analysis reveals stress-promoted chemoresistance in metastatic ovarian cancer.
Zhang, K., Erkan, E. P., Jamalzadeh, S., Dai, J., Andersson, N., Kaipio, K., . . . Vähärautio, A. (2022). Science Advances, 8(8), eabm1831.
Comparison of islet isolation result and clinical applicability according to GMP‐grade collagenase enzyme blend in adult porcine islet isolation and culture.
Kwak, K., Park, J. k., Shim, J., Ko, N., Kim, H. J., Lee, Y., . . . Choi, K. (2021). Xenotransplantation (Københaven), 28(4), e12703-n/a.
Comparison of Islet Characterization from Use of Standard Crude Collagenase to GMP-Grade Collagenase Enzyme Blends in Preweaned Porcine Islet Isolations.
Corrales, N., Park, S., Lau, H., Xu, I., Luong, C., Rodriguez, S., . . . Lakey, J. R. T. (2020). Cell Transplantation, 29, 0963689720977835