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Clinical Laboratory Testing

In deep consideration of the above, we, SRL Medisearch, collect the samples from the investigator's sites with full use of the SRL's collection network and alliances situated in more than 80 locations in Japan.
Also the recent inauguration of SRL's central laboratory exclusive for clinical trials at Sagamihara with a laboratory testing system in compliance with GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) will make more competent the services of SRL Medisearch for clinical trials.

Central Laboratory for Clinical Trials

SRL Sagamihara Laboratory functions as “Central Laboratory dedicated to clinical trials”in compliance with the following guidelines.

Pre-clinical and
Non-clinical Study
Analysis of various drugs and metabolites as well as development and validation of analysis methods using API 4000.
Measurement of drug concentrations using methods such as chromatography, immunoassay, and bioassay as well as pre-validation and validation of assay systems.
Toxicokinetics testing
GLP-compliant testing
Virus testing of pharmaceuticals SNPs testing
Hormone testing and biochemical testing using animal samples
Specialized kits are available according to animal species.
By offering our frontier technology,we will customize to your needs for specific measurement methods.
Clinical Study
Pharmacokinetic study
Analysis of various drugs and metabolites as well as measurement of drug concentration using methods such as chromatography and immunoassay.
Antibody titration
Measurement of antibodies against various drugs and antibodies originating in the host using methods such as EIA, RIA and bioassay.
Various tests available
  • General test
    (including peripheral blood and urine tests)
  • Biochemical test
  • Measurement of bone metabolism
  • Endocrinology test
SRL Medisearch Inc. offers more than 1,600 assay items currently.We are also willing to develop new assay systems to meet your request. Please ask our sales representatives for details.

the Hachioji laboratory

The College of American Pathologists (CAP), an authoritative external organization that certifies accuracy, has certified the SRL’s main laboratories, including the Hachioji laboratory complex, for compliance with the standards of facility inspection.

  • Tumor-related test
  • Plasma protein analysis
  • Virology test
  • Immuno-serological test
  • Blood coagulation test
  • Genetic test
    [Genetic/chromosomal analyses] HLA
  • Therapeutic drug monitoring
  • Cellular immunity test
  • Pathology test
  • Cytology test
  • Microbiological test
  • Research-oriented test
    (cytokine and other immunology test)
  • Hard tissue test
    (Non-decalcified)

Support for Molecular Targeting Drug Development(Biomarker screening)

Breast cancer tissue EGFR(HER1)
(Breast cancer tissue EGFR(HER1))
Breast cancer tissue HER2/erbB2
(Breast cancer tissue HER2/erbB2)

The proteins expressed by coding of the genes are indispensable for the contemporary exploration of molecular targeting drugs. The target genes in the expressed protein of cells or tissue can be localized by immunostaining with a specific antibody.
With our abundant experience in biomarker screening at the drug development stage and phases I through III we can fully support GCP-based clinical trials.

■Biomarkers

  • EGFR（HER1）
  • HER2/erbB2
  • Topo2
  • K-RAS
  • C-KIT（DNA）and other various biomarkers

■Cell cycle-associated biomarkers

  • p16,p21,p27,p53
  • Cyclin A,Cyclin B,Cyclin D,Cyclin E
  • CDK2,CDK4,CDK6
  • cdc 2,Rb

■Apoptosis associated biomarkers

  • DNA fragmentation(TUNEL method)
  • Cell membrane symmetry change
  • Apoptotic protein expression
    (bax, bcl-2, caspase-3, etc.)

Viral Safety Evaluation

SRL, Inc., as a pioneer in Japan, conducts the testing to evaluate the safety of “drugs of biological origin” and “drugs of specified biological origin” which have become indispensable to the application for drug production licenses due to the amendment of the Pharmaceutical Law in 2005.

■Viral safety test

  • High-sensitivity virus detection such as PCR
  • Virus detection using cultured cells
  • Virus detection using animals

■Virus clearance test in the production process

This test is designed to evaluate the virus clearance rate in the physical and chemical treatment in the production processes, namely in the thermal, SD, acid, filtering, etc.

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