Regenerative medicine(Quality assurance tests / Non-clinical safety tests)

We perform the quality tests of the regenerative medicine product by GMP.

We support the control of manufacturing process and the quality testing for the regenerative medicine products by conducting analytical testing under GMP.New experiment facility available for the safety evaluation of regenerative medicine products was completed in June 2016.

Quality assurance tests

Applicable Testing:

  • Acceptance testing for raw materials (plasma, platelet, cell suspension, etc.)
  • Analytical testing for control of in-manufacturing process (culture supernatant, cell suspension, etc.)
  • Release testing for products (cell suspension, etc.)

Measurement Item:

  • Sterility test (membrane filtration method, direct method)
  • Endotoxin test (colorimetric method, turbidimetric method, gel-clot technique)
  • Mycoplasma test (NAT method by RT-PCR)†
  • Method validation
    ・ Sterility test: Confirmation of absence of antimicrobial activity factors

    ・ Endotoxin test: Test for interfering factors
    ・ Mycoplasma testing: Specificity and detection limit

Real-time PCR System
Roche LightCycler® 480 system II

LC/MS/MS
TRIPLE QUAD 5500

Non-clinical safety tests

New experiment facility available for the safety evaluation of regenerative medicine products was completed in June 2016 and CPhS has proceeded with evaluations such as cell proliferation characterization analysis, soft agar colony formation test, tumorigenicity test using immunodeficient mouse

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Inquiries about our services

Click here if you are interested in outsourcing your operations to us.

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