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Rohto Pharmaceutical Co., Ltd.'s sterile drug product manufacturing technology
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Manufacturing control in accordance with pharmaceutical manufacturing
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Conforming to the Standards for Biological Ingredients (obtained the qualification certificate for materials of regenerative, cellular, and gene therapy products)*1
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Obtained FIRM Mark certification with ISO 20399 as the applicable standard.*2
R:STEM Medium for hMSC High Growth
R:STEM Medium for hMSC High Growth obtained FIRM Mark certification (Certification No.: CAM-0001) on May 17, 2024, becoming the first to receive it in Japan.
https://firm-mark.com/services/
In addition, hMSC expansion AOF w/o Phenol Red obtained FIRM Mark certification (Certification No.: CAM-0002) on May 23, 2025.