CultureSure® Media Supplement Series
FUJIFILM Wako offers the CultureSure® line of reagents that have been specifically formulated and validated for use in cell culture applications. They are ideal for clinical research and product development in the fields of regenerative medicine and biopharmaceutical engineering.
CultureSure® media supplements (amino acids, vitamins, carbohydrates, and inorganic salts) are free of animal-derived components. These reagents are also tested for endotoxin levels and the contamination of microorganisms (including mycoplasma species). Moreover, they are produced by manufacturers with effective change management practices. These stringent standards in quality control ensure the safety and reliability of this media supplement series.
What Are CultureSure® Media Supplements?
- Animal Component Free
FUJIFILM Wako defines animal component-free products as those manufactured from materials that do not contain any animal-derived ingredients at either the primary or secondary level. - Cell Culture Tested
These media supplements are endotoxin-free. They are also tested for mycoplasma and other microbial contamination. - Class 100,000 Certified
Our reagents are manufactured in a certified clean-room environment.
Managing a Seamless Transition to Mass Production
- Implement an effective change management program.
- Supply CultureSure® media supplements in bulk quantities.
- Achieve and maintain the high levels of quality required for product commercialization.※
※ As CultureSure® products are used as reagents, they are manufactured in accordance with the ISO standards. Upon request, they can be produced under the control of our in-house standards that generally comply with the requirements of GMP.
Supplementary Information: Examples of Regulatory Requirements for Different Grades of Biomedical Products
| Regulatory Requirement |
Reagent Grade |
CultureSure® | Japanese Pharmacopoeia Products |
|---|---|---|---|
| Manufacturing Environment | Uncontrolled | Cleanroom | Cleanroom |
| Change Management | Inapplicable | Applicable | Applicable |
| Document Management | ISO | ISO | GMP |
| Product Testing | Japanese Industrial Standards | Contamination of endotoxins and microorganisms (including mycoplasmas) |
Japanese Industrial Standards |
Aichi M-1 Plant: A Facility Dedicated to Culture Media Manufacturing
This factory was established to produce culture media and reagents for the commercialization of biologics and regenerative medicine products.
[FUJIFILM Wako’s GMP-class manufacturing facility]
- Carefully managed and operated for culture media production, using the ICH Q7 guideline (GMP Guide for Active Pharmaceutical Ingredients) as a reference
- Completely validated in accordance with regulatory requirements
ranging from facility and utility maintenance to manufacturing, testing, and cleaning processes - Fully guaranteed to meet stringent quality requirements.
We ensure that our raw powder materials for culture media are sourced only from reputable suppliers who maintain appropriate manufacturing practices.
FUJIFILM Wako can also produce customized media. For more information, contact our sales representatives in your area.
Product List
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Amino acids
Sugar
Vitamins
Inorganic salts
Other
For research use or further manufacturing use only. Not for use in diagnostic procedures.
Product content may differ from the actual image due to minor specification changes etc.
If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.