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Updated: Jul 3, 2026

Biological Compatibility Profile on Biomaterials for Bone Regeneration
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Biological Compatibility Profile on Biomaterials for Bone Regeneration

Published on: November 16, 2018

Reference biomaterials for biological evaluation.

Leena Joseph1, Arumugham Velayudhan, Muraleedharan V Charuvila

  • 1Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India. leenaj@sctimst.ac.in

Journal of Materials Science. Materials in Medicine
|July 24, 2008
PubMed
Summary
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Biological evaluation studies need reliable controls. This study details developing in-house reference materials, like titanium pins for muscle implantation, due to the lack of affordable certified reference biomaterials.

Area of Science:

  • Biomaterials Science
  • Medical Device Evaluation
  • Reference Materials

Background:

  • Biological evaluation studies exhibit significant variability, necessitating reliable experimental controls.
  • Existing certified reference materials for biomaterials are often unavailable or unaffordable.
  • This gap highlights the need for developing laboratory-developed reference materials (RMs).

Purpose of the Study:

  • To provide an overview of the global status of reference biomaterials.
  • To outline the essential steps for developing in-house reference materials.
  • To present a case study on producing titanium pins as negative controls.

Main Methods:

  • Reviewing the international landscape of reference biomaterials.
  • Detailing the strategic characterization process for in-house RMs.

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  • Producing and characterizing commercially pure titanium pins.

    • Main Results:

    • A comprehensive strategy for developing in-house reference materials is essential.
    • Commercially pure titanium pins were successfully produced and characterized.
    • These pins are suitable for use as negative controls in muscle implantation studies.

    Conclusions:

    • Developing in-house reference materials is a viable solution to address the unmet need for affordable biomaterial controls.
    • Standardized methods for characterization are crucial for the reliability of laboratory-developed RMs.
    • The case study demonstrates a practical approach to creating essential controls for biological evaluations.