Microbiological evaluation, including virus safety testing of regenerative medicine

We provide services from analytical method development to quality testing, by utilizing our extensive analytical technologies and knowledges.
We conform to the Japan’s Reliability Criteria*1, and GMP (Japan, USA, and Europe).
As we will propose various options in response to our clients’ requests, Please feel free to contact us.

• *
  1: Article 43 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

• Microbiological testing is performed with our quality system in accordance with the laws and regulations, such as the Japan’s Reliability Criteria *1 and GMP (Japan, USA, and Europe), except for GLP.
• Samples range from Master Cell Bank (MCB), Working Cell Bank (WCB), to products, process intermediates, culture supernatants, and raw materials.
• Release testing for commercial and investigational products
• Sterility test, bacterial endotoxins test and mycoplasma test, directed in the Japanese Pharmacopoeia, and other pharmacopeias, if requested.
• Rapid sterility test, where test results will be available within 3 days after receiving samples in the earliest case.
• Virus safety tests for eight types of virus, required by the Ministry of Health, Labour and Welfare "Guidelines on ensuring quality and safety of cell and tissue-based products”.

Please inform us of test items and methods, and necessity of regulatory compliance depending on the purpose of the study. We will ask you the volume and transportation method of samples needed for the tests.

• 1.
  Preliminary testing to determine the applicability of test method, usually not under any regulations.
• 2.
  Validation of analytical procedures (Suitability of test methods, including confirmation of growth factors and inhibitors)
• 3.
  Quality Testing (Measurement of samples is conducted under GMP, if necessary.)

Please provide us with the following information in advance.
If samples should be handled under Biosafety level (BSL) 3 or higher or if the safety of samples cannot be ensured, we may not accept them.

• Information on infectivity of samples and pathogenic micro-organisms (origin, BSL, the methods that shows non-pathogenicity, status of inactivation, etc.)
• Whether β-lactam antibiotics are used or not
• Whether it is a genetically modified organism or not

When sending samples obtained from the human body to us, please review and get approval from your Ethical Review Committee, in accordance with the "Ethical Guidelines for Medical and Biological Research Involving Human Subjects", and take necessary measures required by this guideline.