島津ダイアグノスティクス List of Products and Services

Aseptic testing is generally required to be conducted using the final processed product as the test specimen, based on the aseptic testing method specified in the Japanese Pharmacopoeia General Test Method (4.06). This testing method requires a culture period of more than 14 days to obtain results. On the other hand, for specific cell processing products, it is desirable to obtain the results of the aseptic test before administration to the patient. However, due to the time required to obtain results from the pharmacopoeia-compliant aseptic test, it is often the case that test results are determined after administration. Additionally, for specific cell processing products, due to limitations such as the amount of specimen available and the time required for testing, it may not be possible to apply the aseptic testing method compliant with the pharmacopoeia. In such cases, consideration may be given to the "Rapid Microbial Testing Method" (as referenced in the 18th revision of the Japanese Pharmacopoeia). Our company has developed a rapid aseptic testing method using PCR that covers a wide range of microorganisms, including not only those listed in the pharmacopoeia but also environmental bacteria and human-derived bacteria, allowing for detection in a short time.

• Real-time PCR

This is an in-house developed medium that does not use animal components and has a composition similar to Essential8. It uses highly heat-stable ingredients, allowing for Weekend-free culture without the need for medium exchange on weekends. Stable supply is possible, and we can also provide information regarding the composition.

• Culture medium

Features of HYDROX - Derived from chemically synthesized polymers - Ready-to-use, can be stored at room temperature - Forms spheroids simply by seeding cells - Easy recovery of cells after culture - Confirmed usefulness data for culturing liver and nerve cells Currently, in three-dimensional culture, animal-derived components are primarily used as scaffolding materials to promote interactions between cells and between cells and the extracellular matrix. However, the use of animal-derived components has raised issues regarding reproducibility, safety, and handling difficulties. Shimadzu Corporation's three-dimensional nanofiber "HYDROX" is a new type of three-dimensional cell culture substrate using polysarcosine-polylactic acid polymer. It enables three-dimensional culture of various types of cells simply by seeding a cell suspension.

• Other Culture

Features of our Mycoplasma Detection Test Liquid Medium - Composition based on biological product standards - Demonstrates growth capability that meets the performance testing criteria of the Japanese Pharmacopoeia and biological product standards - Ready-to-use liquid medium that can be directly used for Mycoplasma detection tests based on various official standards - Usable for one year when stored at -20°C or below - Manufactured domestically

• Other cell research

MSH-EV medium is a fully synthetic medium for the production of exosomes from human mesenchymal stem cells (MSCs). It has minimal contamination with microparticles, making exosome purification easier. It can support both expansion culture and exosome production in the same medium.

• Human cells

This is a serum-free medium that does not contain components derived from non-human animal sources (xeno-free) (it does not contain bovine fetal serum (FBS) or human platelet lysate). The protein components consist solely of recombinant proteins expressed in microorganisms and human serum-derived albumin (pharmaceutical grade).

• Culture medium

This product shows a higher proliferation support capability than the basic medium when supplemented with "UltraGRO" (AventaCell BioMedical product) and MSF-Supplement A.

• Culture medium

Shimadzu Diagnostics offers unique media developed in-house. Samples are available for all, so please feel free to contact us.

• Culture medium

The human mesenchymal stem cell proliferation medium MSF-BM and the serum-free culture medium DCO-K for immune cell therapy research have obtained the "Confirmation of Material Suitability for Regenerative Medicine Products" from the PMDA (Pharmaceuticals and Medical Devices Agency). Both media have been confirmed to comply with the standards for biological raw materials, allowing them to be used safely as raw materials for regenerative medicine products. For inquiries regarding the confirmation of material suitability for regenerative medicine products (PMDA): https://www.pmda.go.jp/review-services/f2f-pre/consultations/0035.html They are listed in the "List of Products that Have Obtained Confirmation" on the FIRM (Regenerative Medicine Innovation Forum) website. https://firm.or.jp/standard/support-s/1732/

• Culture medium

The gene detection kit VirFinder for virus denial testing can detect eight types of viruses listed in the law concerning the assurance of safety in regenerative medicine and other fields.

• Other Culture

We would like to introduce our "Contract Manufacturing Service for Cell Culture Media." Manufacturing is possible in facilities where airborne particles and microorganisms are controlled. The raw materials used comply with biological origin material standards. Operations are managed based on the ISO 9001 quality management system. 【Features】 ■ Capable of producing both powdered and liquid media ■ Thorough manufacturing and quality control ■ We also offer analytical services as an option to provide suitable media - Simultaneous analysis of 95 components contained in the media - Effective when you want to know important indicators for managing cell culture processes and components that provide hints for media improvement *For more details, please refer to the PDF document or feel free to contact us.

• Culture medium

The "Cell Culture Medium Analysis Service" conducts component analysis using LCMS to examine changes in medium components before and after culture, as well as metabolites secreted by cells. This service is effective when you want to know about the components, providing data to achieve a suitable medium for the cells you use. We provide medium samples, so please feel free to contact us. 【Features】 ■ Simultaneous analysis of 95 components contained in the medium ■ Important indicators for managing cell culture processes and hints for medium improvement ■ Provision of medium samples ■ Custom manufacturing based on analysis results - GMP grade and research grade options available *For more details, please refer to the PDF materials or feel free to contact us.

• Culture medium

"Myco Finder" is a solid-phase kit that simplifies the complex procedures of mycoplasma detection tests and allows for rapid testing. Since the reagents are solid-phased on the test strip, they only need to be dissolved during testing, which reduces the risk of contamination. Furthermore, with the adoption of high-speed amplification enzymes, the detection time is shorter than before, taking less than one hour from the start of amplification, allowing for results to be determined within a day. 【Features】 ■ No reagent preparation required ■ Detection time is within one hour from the start of amplification ■ High sensitivity ■ Can be stored in a cool place (2–8°C) *For more details, please refer to the catalog or feel free to contact us.

• Other purification and extraction