Testing Service

Virus & Bacteria Testing

PharmaBio offers comprehensive genetic tests of pathogenic viruses and microbes, focusing on human-infecting viruses

What PharmaBio offers is highly sensitive testing to detect and quantify human-infecting pathogens, including viruses, mycoplasmas, bacteria, fungi, and protozoa, using a genetic testing method (Nucleic acid Amplification Test, Multiplex qPCR) developed and validated in-house. We provide testing to rule out exogenous infectious agents as part of manufacturing processes for cell/tissue based drugs and cell bank quality control.

Viral testing items

  • RetroVirus
    HIV1, HIV2, HTLV2, HTLV2
  • RNA Virus
    HCV, Influenza, Rubella Virus, etc. A total of 8 items
  • DNA Virus
    HBV, EBV, CMV, Parvo B19, HSV, VZV, etc. A total of 14 items

Microbial testing items

  • Bacteria
    Mycoplasma, P.Aeruginosa, Chlamydia, etc. A total of 7 items
  • Fungi
    Aspergillus, P.carinii, Candida etc. A total of 5 items
  • Protozoa
    Acanthamoeba, Toxoplasma, etc. A total of 4 items

Biological Safety Testing

PharmaBio offers microbial safety testing to assure the sterility of cell and tissue derived medicines

Microbial safety tests, such as sterility test, mycoplasma test, and endotoxin test are required at each stage of the manufacturing process to assure the sterility of final products, including cell medicines.

Biological safety testing items

  • Sterility testing
  • Mycoplasma testing
  • Endotoxin testing

Non Clinical Pharmacological Safety Testing

PharmaBio is also able to handle non-clinical testing for various types of toxicity, safety, and drug efficacy/pharmacology under GLP/non-GLP conditions depending on customers’ needs

Non clinical pharmacological safety testing items

  • Single-dose toxicity
  • Repeated dose toxicity
  • Tumorigenicity
  • Karyology
  • Genotoxicity
  • Antigenicity
  • Pharmacological test

Our Business

We contribute to medical and social progress by pioneering potential new therapies as we pursue the development of cell and tissue based medicines for the Japanese market.