Rohto's medium is Animal Origin Free (AOF) serum-free medium.

Culture media used for cell culture are broadly classified into serum-containing media and serum-free media.

Among serum-free media, there are also Xeno-Free media that contain no components derived from non-human animals; however, Rohto Pharmaceutical’s medium is an Animal Origin Free (AOF) serum-free medium that has been verified to contain no animal* or human-derived components.

The definition of animal includes the entire animal kingdom (including vertebrates and invertebrates, but excluding protozoa).

Animal- and human-derived component–free medium (AOF medium)

The reason why Rohto Pharmaceutical developed the “AOF medium”

We want to share this technology originated from the development by Rohto Pharmaceutical with as many people as possible

In 2013, Rohto Pharmaceutical made a full-scale entry into the field of regenerative medicine, and in collaboration with universities, is conducting clinical trials for the treatment of liver cirrhosis, severe heart failure, and other conditions.

To initiate clinical trials and ensure patient safety, the media used for cell culture must also meet various regulatory requirements. In pursuing patient safety, we arrived at the development of an “AOF medium” that does not use animal- or human-derived raw materials.

We at Rohto Pharmaceutical hope that more people will be able to use this technology, originated from our development of regenerative medicine.

Difference between serum-containing medium and serum-free medium

What is Serum-containing medium?

Serum is an ingredient extracted from animal or human blood.

In general, for cell culture, media supplemented with bovine- or human-derived serum are used to promote the maintenance and proliferation of cells. These media are referred to as serum-containing media.

What is Serum-free medium?

Serum-free medium refers to a medium in which serum is not added during cell culture.

Without using serum, the addition of specific proteins or components enables the maintenance and proliferation of cells. Because it reduces variability in components attributable to serum, batch-to-batch performance differences are less likely to occur; it also reduces risks associated with serum, such as pathogen transmission, and immunogenicity. These media are classified into several types depending on differences in composition and origin.

Products

  • R:STEM®

    AOF medium for culturing mesenchymal stem cells
    R:STEM® Product name: R:STEM Medium for hMSC High Growth(Ref. No. EM1-500)

  • StemNavi™

    AOF medium for production of exosomes/extracellular vesicles (EVs)
    StemNavi™ Product name: hMSC expansion AOF w/o Phenol Red( Ref. No. RS1-500)

Five “reductions”.

  1. Reduction in the risk of viruses caused by the use of serum

  2. Reduce the risk of changes in cell properties caused by culture-medium-derived EVs.

  3. Reduce the risk of cytotoxicity originating from antibiotics.

  4. Reduction in the time required for lot checks

  5. Reduction in the time and effort of pretreatments such as addition of supplements

(EVs: extracellular vesicles)

Thorough quality control of each process in manufacturing

  1. Rohto Pharmaceutical Co., Ltd.'s sterile drug product manufacturing technology

  2. Manufacturing control in accordance with pharmaceutical manufacturing

  3. Conforming to the Standards for Biological Ingredients (obtained the qualification certificate for materials of regenerative, cellular, and gene therapy products)*1

  4. 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.