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This document specifies the requirements and methods for characterization and evaluation of recombinant collagen as starting material for implants, including requirements for quality assessment and quality control, test items and corresponding methods, packaging and storage.
This document is intended to be used for the quality assessment and quality control of recombinant collagen.
This document is not applied for recombinant collagen which will be used as medicine for the treatment of collagen related genetic diseases, such like recombinant collagen VII for the treatment of Epidermolysis bullosa.
Collagen is one of the most widely used protein material for surgical implants. Recombinant collagen has become an attractive alternative to animal-derived collagen materials in the cosmetic, pharmaceutical and medical devices industries, due to their high water solubility, low immunogenicity, no viral contamination, small batch variation and easy fabrication. In addition, recombinant collagen usually have more accessible biologically active sites even in the triple-helix structural regions than animal-derived collagen, which promote easy interaction with cells or other bioactive molecules, hence, in aspects such as promoting cell recruitment and adhesion for tissue repair, chelating of metal ions for antioxidation, enrichment of platelets and clotting factors for haemostasis, etc., recombinant collagen may exhibit higher biological activity than their natural counterparts. Recombinant collagen is prepared using recombinant DNA technology to genetically manipulate and/or modify the gene encoding desired human collagen protein, bringing the target gene into an appropriate host cell (bacteria, yeast or other eukaryotic cells, etc.) using a plasmid or viral vector, expressing and translating it into collagen or a collagen-like peptide, followed by steps such as extraction and purification. Recombinant collagen differs significantly from animal-derived collagen in terms of amino acid sequence, structure, impurity profile, etc. Therefore, standards pertaining to animal-derived collagen cannot cover the quality requirement of recombinant collagen. In addition, due to the different types and sequences of the gene cording fragments used for recombination, and the differences in the expression systems, the products are very different, such as in amino acid composition, molecular weight, structure, and types of impurities compared to natural collagen. It is necessary to perform a comprehensive characterization, quality assessment and strict quality control. The quality assessment and quality control of recombinant collagen are related to molecular weight, structural characteristics, complexity of quality attributes and manufacturing processes. The quality control system mainly includes the quality control of raw and auxiliary materials, manufacturing processes and process control, and testing of final products. All kinds of impurities shall be removed or reduced to an acceptable level through the combination of finished product detection, process control and process verification. Currently, there is no any existing ISO (TC150, TC150/SC1, TC150/SC7, TC276) and IEC deliverables on recombinant collagen. Although a general technical requirement for processing and manufacturing, and quality control of recombinant protein products for human therapeutic use as medicine have been included in the Pharmacopoeia of almost countries, but the recombinant collagen as starting materials used for surgical implants is significantly difference with general recombined proteins used in medicine, it is still needed to develop an international standard of recombinant collagen as starting material for surgical implants. (Please use this field or attach an annex)
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