Product Information
StemFit™ Basic03 GMPCat No:34770

StemFit Basic03 GMP is an animal-origin free, defined medium for human pluripotent stem cell culture. This medium is capable of maintaining human ES and iPS cell under feeder-free culture conditions.This product is manufactured under GMP guidelines.

Animal-Origin Free & regulatroy compliance
for CGT product manufacturing

Animal or human derived components, such as serum derived albumin, or animal cell derived recombinant proteins, are known to carry a risk of hazardous viral contamination for cell therapy. Therefore, StemFit is designed and manufactured under a strict animal origin free policy and is free from animal or human derived components, as referred in USP<1043> and ISO20399. This makes StemFit Basic03 a gold-standard hPSC expansion media for clinical research. To this end, the Japanese PMDA was consulted on the formulation and manufacturing process and found that Basic03 satisfies all requirement of ancillary materials for cell and gene therapy (CGT) manufacturing. Additionally, StemFit offers a GMP compliant product, Basic03 GMP, which is manufactured under applicable GMP guidelines and is thus preferable for CGT products.

Superior performance in single-cell expansion

Single-cell expansion is an ideal method for CGT product manufacturing since it allows well-controlled, reproducible, and efficient cell expansion. StemFit is optimized for the single-cell expansion method and shows higher cell survival rate in single-cell conditions, which enables efficient and genetically stable cell growth without karyotypic abnormalities.
CGT Catapult, an independent center of excellence to advance the growth of the UK CGT industry, performed a comprehensive comparison program for hPSC culture media and found that StemFit Basic03 to have the highest performance in clinical hPSC expansion.

Weekend-Free Feeding

Traditional culture medium requires daily medium changes to maintain hPSCs, which increases the labor cost and risk of human error or contamination in CGT product manufacturing. StemFit allows flexible weekend-free feeding in which hPSC can be expanded healthily without medium change during the weekends. This feature enables researchers to simplify their culture protocol and minimize the labor and culture media costs.

— Materials Provided —1

— Media Preparation —

StemFit Basic03 GMP is provided frozen as a 2 component set containing “Liquid A” and “Liquid B” and can be stored at below -20 °C until use. Use sterile techniques to prepare StemFit Basic03 GMP medium.

1) Before use, thaw the frozen “Liquid A” and “Liquid B” with occasional mixing at room temperature (15-25 °C).
Do not thaw, “Liquid B” at 37 °C, as it accelerates the degradation ingredients. 2

2) Aseptically mix medium components by adding the full volume of “Liquid B” to “Liquid A”. Mix thoroughly.
If prepared aseptically, StemFit Basic03 GMPis ready for use. If precipitations are observed, keep the bottle at room temperature until completely dissolved.

3) Add bFGF at 80 ng/ml concentration*.

4) Upon thawing, StemFit Basic03 medium may be aseptically aliquoted and stored at below -20 °C.

5) Before use, warm aliquots to room temperature and use immediately.

6) nce aliquots are thawed, they should be stored at 4 °C for no more than 2 weeks.34
*bFGF concentration can be customized according to the application.

Key points for successful culture

This product does not contain basic fibroblast growth factor
(bFGF). Therefore, 80 ng/ml bFGF should be supplemented.

Do not thaw, “Liquid B” at 37 °C, as it accelerates the degradation of medium ingredients.

Thawed StemFit Basic03 GMP medium may be stored at 2-8 °C for up to two weeks.

We recommend storing the medium protected from light

— Precaution and Disclaimer —

StemFit Basic03 GMP is for research and further manufacturing use only. It is not for diagnostic use, therapeutic use, or as a food.