New
In accordance with the revision of ICH-Q5A, we have begun accepting contracts for viral safety testing using Next Generation Sequencing (NGS) (GMP/GLP grade).
Viral Safety Testing
ViruSure, for which we are an agent, carries out everything from GMP production of cell banks (MCB, WCB) and virus seeds (MVS, WVS) required for the manufacture of biopharmaceuticals to virus safety testing.We accept requests for packages ranging from establishment of master cell banks to QC testing, as well as requests for single tests only.
We can also propose the necessary test package based on information about your manufacturing process and raw materials.
Please feel free to contact the Lunapath Toxicological Pathology Laboratory for ViruSure testing requests and inquiries.
About ViruSure
ViruSure is a contract research organization (CRO) specializing in viral safety testing and viral clearance testing as specified in the ICH-Q5 guideline for quality testing of biopharmaceuticals, "Quality of Biological Products."
We conduct various viral safety tests in our state-of-the-art GLP/GMP certified laboratories in accordance with Japanese, European, and US guidelines.
We also provide consultations with virus risk assessment experts, and we act not simply as a CRO that undertakes testing, but as your development partner, providing virus risk assessment strategies tailored to your needs.
Contracted Test Items
Cell Bank & Virus Seed
GMP manufacturing: MCB, WCB, MVS, WVS
Characterization: germ-free, mycoplasma, etc.
Viral Safety Testing
Sterility test / Mycoplasma test / Endotoxin
In vitro adventitious virus testing
Retrovirus testing:
TEM/FPERT/Infectivity assay
9CFR Bovine/Porcine in vitro assay
Replication Competent Virus Tests: RCA, RCL, RCR
In vivo adventitious virus testing:
Mouse / Guinea pig / Embryonated chicken egg
Antibody production test: MAP/HAP
Species-specific virus-negative testing (qPCR):
Humans / Cattle / Pigs / Insects / Birds / Monkeys / Horses
Next-generation sequencing ( NGS)
Molecular Biological Testing
Identity: qPCR / DNA barcoding / DNA fingerprinting
Genetic stability:
Gene copy number/sequence analysis
Viral & Prion Clearance Testing
Viral Clearance Test
Prion Western blot analysis
In vivo prion assay
GMP storage
In vivo testing
Biodistribution studies
Tumorigenicity test
Prion bioassay
Ultra-low temperature freezer (-60ºC)
Cryofreezer (-130ºC)
Liquid nitrogen tank (-150ºC)
Target modality
ViruSure offers testing for a variety of biologically derived raw materials and active pharmaceutical ingredients.
Test sample:
Master Cell Bank (MCB), Working Cell Bank (WCB)
Master virus seed (MVS), working virus seed (WVS)
Unrefined Bulk (UBH)
drug substance
Target modalities:
Recombinant Protein
Blood-derived products
vaccine
Gene and Cell Therapy Products
Animal-derived products
cultured meat
