Laboratory Test Request

FDA GMP Osteoinductivity Studies of Allograft Bone Products (In Vitro and In Vivo)

Project Description

USA LABORATORY (Preferred)
MULTIPLE TESTS
FDA GMP Compliant and ISO/IEC 17025 Accredited Medical Device Laboratory with an established Quality Management System needs Bioanalytical Laboratory for the following in vitro and in vivo osteoinductivity studies for allograft bone products:
assessment of the osteoinductive potential of allograft bone product by the following methods:
 In vitro assessment: Alkaline phosphatase (ALP) assay using C2C12 cell line.
 In vivo assessment: Histopathology (by H&E) of bone formation in athymic rat model in line with ASTM F2529-13.

Labs which offer testing of osteoinductive potential by any other methods would also be of interest.

Project Information

Number:21-02371

Industry:Biotechnology

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Biologics,Biomaterials,Biotechnology,Bone Grafts,Life Sciences,Medical Devices,Medical Devices - Sterile,

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