Service Details
Drug Discovery Innovation Center: Infectious Disease Facility (BSL3)
The Infectious Disease Facility (BSL3) is one of the few facilities in Japan capable of conducting tests under standards suitable for regulatory applications in drug development. At this facility, we conduct tests in compliance with biosafety guidelines for handling pathogens, applicable laws and regulations, and relevant regulatory guidelines.
Facility Information
- Location
- 1285 Kurizaki-machi, Uto-shi, Kumamoto
- Operation Start
- April 1, 2026
- Facility Area
- 264 m2 (BSL2 and 3)
Features
- Regulatory Application Support within GLP-Compliant Facilities
GLP-trained staff conduct testing operations under a robust operational system for regulatory applications, including SOP maintenance and quality oversight by the QAU.
- Comprehensive Biosafety, Storage, and Analytical Infrastructure
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- Biosafety cabinets
- CO2 incubators
- Centrifuges
- Autoclaves
- Extensive Range of Testing & Assay Services
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- Isolation, culture, and identification
- Quantitative culture measurements
- Neutralizing and HI antibody titers
- Drug susceptibility testing
- Inactivation testing
- ELISA-based analyses and measurements (Antigen detection)
Antibacterial & Antifungal Drugs
1.Bacterial and Fungal Measurements (In Vitro Testing)
We conduct a wide range of bacterial and fungal tests to meet diverse needs across all stages, from R&D to post-marketing surveillance. We also provide technical support for clinical trials and investigator-initiated research.
① Drug Susceptibility Testing for Antibacterial and Antifungal Agents (CLSI Compliant)
We perform susceptibility testing for various bacterial species using standardized methods based on CLSI (Clinical and Laboratory Standards Institute) guidelines. We provide analysis reports including MIC50 / MIC90, MIC distribution, and susceptibility classification.
Drug-resistant strains have also emerged among fungal species, making drug susceptibility testing essential for effective treatment. Further progress in fungal surveillance and drug discovery research is expected. Mediford has extensive experience in conducting drug susceptibility testing for fungi.
② Serotyping and Genotyping
Example: Pneumococcal Serotyping
Serotyping involves reacting antisera with bacteria isolated and cultured from patients and identifying capsular swelling caused by polysaccharides surrounding the bacteria through staining (Quellung reaction). Serotype identification is critical for epidemiological surveys. Mediford has extensive experience in pneumococcal serotyping.
Streptococcus pneumoniae is a bacterium that causes infections such as pneumonia, otitis media, sepsis, and meningitis in the elderly and children. In particular, Invasive Pneumococcal Disease (IPD)—an infection of normally sterile sites—tends to be severe and is associated with high mortality rates.
Images cited from: "Invasive Pneumococcal Disease Pathogen Detection Manual"
Example: Genotyping
Multilocus Sequence Typing (MLST) is a method used to classify isolates into Sequence Types (STs). It involves sequence analysis of multiple housekeeping genes to pattern species-specific nucleotide sequences as a gene set. This patterned sequence set then serves as a database to characterize and classify unknown isolates. Mediford has a proven track record with Clostridioides difficile. C. difficile infection is a gastrointestinal infection that often develops when the gut microbiota is disturbed, such as by antibiotic use. Typing by MLST is invaluable not only for hospital infection control but also for tracking infection routes on a global scale.
③ 16S rRNA Microbiota Analysis
Our 16S rRNA Microbiota Analysis is a high-precision analytical solution designed to visualize the composition and characteristics of microbial communities. Although the 16S rRNA gene is highly conserved among bacteria, it contains species-specific sequence variations, making it an ideal target for comprehensive microbiota profiling. Using this gene region as a marker, our analysis reveals the types and relative abundance of bacteria present in samples, supporting a wide range of research needs.
Potential Applications
- Microbial testing of products and facilities
- Identification of causative bacteria in quality-related issues
- Microbial evaluation for new product development
16S rRNA Microbiota Analysis Workflow
- DNA extraction from samples (e.g., oral or skin swabs)
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DNA Extraction Instrument:
Maxwell® RSC 48 Instrument (Promega)
- Amplification of target 16S rRNA gene regions
Addition of Index/Adapter sequences to PCR products (library preparation)
- Library purification
- Library quantification
- Measurement of DNA concentration
- Analysis using Illumina sequencer
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MiSeq System (Illumina)
- Import of fastq.gz files into CLC Genomics WorkBench
- Quality Check (QC) and adapter removal
- OTU clustering
- Bacterial classification of OTUs
Distribution graphs for each sample
(e.g., Stacked bar charts based on OTU clustering)
- Delivery of the analysis report (electronic format)
- We utilize internationally recognized taxonomic databases such as SILVA and Greengenes. The resulting sequence data are classified based on a highly accurate taxonomic system, enabling comprehensive and reliable microbiota profiling. Our reports summarize the results in an easy-to-understand format, including percentage (%) comparisons of bacterial groups and genera.
Upon request, we also provide genetic analysis for a wide range of bacteria and fungi, including fungal ITS analysis and antimicrobial resistance gene screening using databases such as ResFinder and CARD.
2.Bacterial and Fungal Measurements (In Vivo Testing)
- ① MRSA Infection
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Bacterial Strains 1 reference strain (ATCC 43300) and 1 clinical isolate Animals Slc:ICR (SPF) mice (female, 4 weeks old) Infection Method Systemic infection via intraperitoneal (i.p.) administration of MRSA Evaluation Parameter Survival rate over 5 days post-infection Test Substances Penicillin G Potassium (30 mg/kg × 2),
Vancomycin (10 mg/kg × 2)Administration Method Subcutaneous (s.c.) administration at 1 and 6 hours after MRSA infection Results In the untreated control group and the Penicillin G Potassium group, all animals died within 4 days after infection with the ATCC 43300 strain. In contrast, no deaths occurred in the Vancomycin-treated group. Effects of Vancomycin and Penicillin on Mice Infected with S. aureus
(ATCC 43300 and Clinical Isolate)
N=10** p<0.01 vs. Vehicle Control
Statistical analysis: Kaplan-Meier method, log-rank test - ② Staphylococcus aureus Infection (Strain provision required)
- ③ Mycobacterium Respiratory Infection (Strain provision required)
- ④ Aspergillus Pneumonia Model (Strain provision required)
- ⑤ Pseudomonas aeruginosa Infection (Strain provision required)
- ⑥ Escherichia coli Infection (Strain provision required)
Antiviral Drugs
1.Viral Measurements (In Vitro Testing)
We conduct a wide range of services, from quantitative and qualitative assays essential for virus evaluation to genome-level analysis.
① Virus Isolation, Culture, and Identification
The isolation and identification of pathogenic viruses is the gold standard for laboratory diagnosis of viral infections. Even when viral loads in a sample are low, the target virus can be isolated by proliferating it within susceptible host cells. Isolated viral strains can then be identified using methods such as fluorescent antibody techniques or neutralization assays.
This process is essential for epidemiological surveys—particularly for monitoring antigenic variation—and for drug susceptibility testing to confirm efficacy and the development of resistance.
② Drug Susceptibility Testing for Antiviral Drugs
Example: Plaque Reduction Assay
This assay evaluates the extent to which an antiviral drug inhibits viral replication. In a typical procedure, cultured cells are infected with the target virus, and the inhibitory effect on viral growth is measured by adding a medium containing the drug (Plaque Reduction Assay). This assay is primarily used to confirm the presence of drug-resistant strains during antiviral drug development and post-marketing surveillance.
(Plaque reduction assay using influenza virus)
③ Neutralizing and HI Antibody Titer Measurement
This is a highly specific method for measuring antibody titers, based on the principle that virus particles lose their infectivity when antibodies bind to viral proteins. Patient serum samples are prepared in 2-fold serial dilutions and mixed with the virus to allow for neutralization. The mixtures are then inoculated into cells highly susceptible to the target virus and cultured for a specific period. The presence or absence of Cytopathic Effect (CPE) is then determined. If no CPE is observed, viral infection is considered to have been inhibited, and the neutralization titer is judged to be positive. The antibody titer (dilution factor) is then reported as a numerical value.
Adenovirus Type 8 infection
HI (Hemagglutination Inhibition) antibody titer measurement is a method that utilizes the ability of certain viruses to agglutinate red blood cells. Patient serum samples are prepared in 2-fold serial dilutions and mixed with viral antigens to allow antigen-antibody reactions to occur, after which a suspension of animal red blood cells is added. If antibodies are present, they inhibit viral hemagglutination. The highest dilution factor at which hemagglutination is completely inhibited is reported as the HI antibody titer.
Both methods are important indicators for evaluating immune status against viruses and play an essential role in infectious disease prevention and management, as well as in vaccine development and post-marketing surveillance.
④ Viral Nucleic Acid Identification and Quantification
(Example: Strain typing by Multiplex Real-time PCR)
By utilizing multiple fluorescent probes, we efficiently perform complex strain typing within a single well. This system can also be used in combination assays with other viruses, such as Respiratory Syncytial Virus (RSV).
cobas z 480 Analyzer
Example: Influenza Virus Multiplex Real-time PCR
2.Viral Measurements (In Vivo Testing)
① Influenza A Virus Intranasal Infection
| Virus | Influenza A/PR/8/34 (H1N1) |
|---|---|
| Animals | BALB/cCrSlc mice (female, 6 weeks old) |
| Group Configuration |
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| Inoculation Method | Intranasal inoculation of a virus solution under ketamine and xylazine anesthesia (Day 1) |
| Administration | Oseltamivir (50 mg/kg/dose) administered orally for 5 days (once on the day of inoculation and twice daily thereafter) |
| Evaluation Parameters | Left lung weight, IL-6 concentration in bronchoalveolar lavage fluid (BALF), and survival rate |
| Results | In mice infected with Influenza A virus, lung weight and IL-6 concentrations in BALF increased compared to those in the uninfected group. Multiple deaths were observed from Day 9 post-infection, and all animals died by Day 12. In contrast, oseltamivir treatment suppressed lung inflammation and improved survival rates. |
Effects of Oseltamivir on Influenza Virus-Infected Mice
② Human Hepatitis B Virus (HBV)
| Virus | Human Hepatitis B Virus (Supplied by PhoenixBio Co., Ltd.) |
|---|---|
| Animals | PXB-mice (Supplied by PhoenixBio Co., Ltd., male, 12 to 18 weeks old) |
| Group Configuration | Control group, Entecavir group, IFN-α group (30 µg/kg) |
| Treatment Period | 6 weeks of administration + 3 weeks of drug withdrawal |
| Administration |
|
| Evaluation Parameter | Serum HBV DNA copy number |
| Results | When PXB-mice were infected with human Hepatitis B virus (HBV), the serum HBV levels increased to 108 copies/mL within 6 to 7 weeks post-infection. Administration of entecavir or IFN-α at 30 µg/kg subsequently resulted in a time-dependent decrease in serum HBV levels. However, HBV levels rebounded once administration was discontinued. The magnitude of this rebound was more than 10 times higher in the IFN-α group compared to the Entecavir group, suggesting that entecavir provides more sustained viral suppression. |
Experimental Schedule
Changes in Serum HBV DNA Copy Numbers in HBV-Infected Human Liver Chimeric Mice (PXB-mice) Treated with Entecavir and IFN-α
**: p<0.01; significant difference compared to the vehicle control group (t-test)
Vaccine Development Support
Mediford has supported infectious disease vaccine development both in Japan and internationally for many years. Vaccine development requires various critical evaluations, including immunogenicity, safety, and pharmacokinetics (PK) in non-clinical studies; efficacy and detailed immune cell characterization in clinical trials and clinical studies; and long-term immune persistence assessments in post-marketing surveillance.
Under appropriate guidelines, Mediford provides long-term evaluations using sustainable and stable measurement systems. With consistent technology and infrastructure, we provide strong support throughout the long-term vaccine development process.
We support a wide range of testing and analytical services required for vaccine development, from sample collection at medical institutions to neutralizing antibody titer measurements and PBMC isolation, contributing to the accelerated development and approval of vaccines.
① Immunogenicity Evaluation
Antibody Titer Measurement
We measure antibody titers against target pathogen antigens using methods tailored to our clients’ objectives. We can support everything from assay development and validation to method transfer (tracing) and the use of commercially available kits. As mentioned above (Viral Measurements), we provide neutralizing antibody titer measurements using viruses, as well as HI (Hemagglutination Inhibition) antibody titer measurements for vaccines against influenza, measles, rubella, Japanese encephalitis, and other viruses. If necessary, we can also evaluate the isotypes and subclasses of the detected antibodies.
Immune Cell Evaluation
Using flow cytometry, we evaluate vaccine-induced immune cell responses and activation. This includes lymphocyte subset analysis of T cells, B cells, NK cells, and others, as well as measurement of various activation marker expression. We can also provide customized analysis strategies for intracellular cytokine production, cytokine-producing cell frequencies, and antigen-specific immune cells.
Cytokine Measurement
Cytokines and chemokines released from immune cells stimulated by vaccine administration are measured using methods such as LBA (Ligand-Binding Assay). With the ECL method, up to 10 items can be measured simultaneously with high sensitivity and precision. With the Bio-Plex method, up to 100 items can be measured semi-quantitatively at once from a small sample volume.
Simultaneous Determination of Multiple Markers (Biomarker Analysis)
Furthermore, the ELISpot assay enables the detection of antigen-specific cells that release cytokines in response to specific antigens at the single-cell level. Mediford is equipped with CTL Immunospot Analyzer and has extensive experience in measuring interferons, interleukins, and other markers using CTL and Mabtech kits.
② PBMC Isolation
In the evaluation of immune cells responding to vaccines and measurements by ELISpot, higher precision can be achieved by increasing the purity of the target cells. For this purpose, it is effective to isolate PBMCs from whole blood for use in these measurements.
PBMCs (Peripheral Blood Mononuclear Cells) are enriched immune cell populations—such as T cells, B cells, NK cells, monocytes, and dendritic cells—from which most red blood cells, granulocytes, and plasma have been removed. They are suitable for evaluating rare cells, such as antigen-specific T cells, and can be stored long-term through freezing.
PBMCs are generally isolated and collected from fresh blood using density gradient centrifugation. However, this process is performed manually for each individual sample, and advanced technical skills are required to obtain high-quality PBMCs. Furthermore, to obtain PBMCs that more closely reflect the in vivo state, an operational system capable of minimizing the time from blood collection to PBMC recovery is essential. These factors are critical for obtaining accurate analytical results in PBMC-based research.
Mediford has over 15 years of experience in PBMC isolation and extensive expertise in obtaining high-purity PBMCs. We can propose the most suitable isolation methods and operational plans based on our clients’ requirements, including intended use, required volume, cost, and the location of medical institutions.
Mediford is also preparing to expand its long-term PBMC storage services in liquid nitrogen.
③ Sample Management (Central Lab Services)
In studies such as vaccine development, where a large number of samples are generated from multiple facilities within a short period, even minor delays or transport errors can significantly impact the progress and outcomes of the entire study. Leveraging our proprietary nationwide collection network, our dedicated and highly trained staff utilize strict temperature control and specialized handling expertise to transport client samples under a high-quality management system.
From advanced analysis of collected samples at Mediford to shipment to external laboratories and long-term storage, we provide one-stop sample management services optimized for our clients’ study designs.
Sample Collection Kit Production, Sample Pickup Service (Central Laboratory Services)
Clinical Testing, Sample Management (Central Laboratory Services)