Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

Importancia y uso:

4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.

4.2 This guide can be used by the following types of users:

4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.

4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.

4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.

4.3 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables (including in situ forming), hybrid medical devices, TEMPs, injectable (including in situ forming) or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of polymerizable collagens and collagen polymeric materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any specific research or medical application.

4.4 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of polymerizable collagen, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.

4.5 As this guide is intended for medical products, there are many relevant guidance documents from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products which should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D in vitro tissue systems. While some relevant documents are referenced in this guide, many more are applicable to devices, biologics, drugs, and combination products.

Subcomité:

F04.42

Referida por:

F3510-21, F2027-25, F3645-25, F3659-24

Volúmen:

13.02

Número ICS:

11.100.99 (Other standards related to laboratory medicine)

Palabras clave:

biomaterials; characterization; collagen-cell interactions; collagen polymer material; polymerizable collagen;