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YY/T 1561-2017: Tissue engineering medical device products - Remnant ��-Gal antigen determination in scaffold materials utilizing animal tissues and their derivative
YY/T 1561-2017
Tissue engineering medical device products-Remnant α-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Tissue engineering medical device products
Animal-derived scaffold material residues α-Gal antigen test
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Organization Engineering Medical Devices Products Technical Committee
(SAC/TC110/SC3) centralized.
This standard drafting unit. China Food and Drug Administration, the Fourth Military Medical University of Chinese People's Liberation Army, crown Hao biotechnology shares
Limited company.
The main drafters of this standard. Xu Liming, Shao Anliang, Lu Yan, Zhao Hong Ni, Jin Yan, Zhang Yongjie, soup silver hi, Zhang Wei, Chai Yuan.
introduction
Animal-derived biomaterials and medical devices containing animal-derived biomaterials or the residual antigens in xeno-organs are such biomaterials and
Main factors of hyperacute rejection and chronic immunotoxicity in organ transplantation. Although animal-derived biomaterials are processed through the process of preparation
After decellularization and antigen removal, the residual xenoantigens still present a risk of causing chronic immunotoxic reactions.
It has been shown that α-galactosyl antigen (α1,3 galactosyle, Alpha1,3Gal or α-Gal) is the cause of animal-derived biomaterials
Or the main target antigen for hyperacute rejection during xenotransplantation. The structure of α-Gal is Galα1-3Galβ1-4GlcNAc-R,
This antigen is a set of complete antigens that galactosyl combines with proteins or lipids on the cell membrane. α-Gal is mainly affected by α-1,3-galactosyl
Α1,3-galactosyltransferase (α-GT) and isoglobotriosylceramide synthase
Or isogloboside3synthase, iGb3S) regulation. There are two galactosyltransferase genes in ancient monkeys because of human and apes
Dislocation of base mutation without expression of α-Gal antigen, but the human intestinal flora continued expression of α-Gal antigen, this stimulus causes the body's immune system
Continued production of anti-α-Gal antibody, circulating immunoglobulin 1% to 3%. Therefore, when the human body receives biomaterials containing α-Gal antigens
Or xenotransplantation can cause hyperacute rejection and chronic immunotoxicity. Animal-derived biomaterials or xeno-organs
The removal of α-Gal antigen during transplantation is one of the keys to reduce the immune rejection and chronic immunotoxicity. At present, there is no animal source yet
Quantitative detection of residual α-Gal antigen in sexual biological materials. This standard by using α-Gal antigen-specific monoclonal antibody M86,
A standard curve was established by using a synthetic Gal-BSA antigen mixed with a Gal antigen-negative matrix as a reference, and a standard curve was established by competitive ELISA
Suppression Methods Quantitative detection of residual α-Gal antigen in animal-derived biomaterials. At the same time, Gal antigen was added to the test system
Negative reference to monitor the sensitivity and specificity of the test.
Competitive ELISA inhibition is a commonly used method, the principle is. First, the standard curve samples and test samples of α-Gal
The antigen reacts with the M86 antibody (consuming a portion of the M86 antibody); then, using Gal-BSA as the solid phase antigen,
The remaining M86 antibody in the supernatant after a reaction; then a standard curve can be used to calculate the content of α-Gal antigen in the analyte. Because of the first
Reaction of α-Gal Antigen with M86 Antibody in a Test Object Reaction of the Residual M86 Antibody with the Solid Gal-BSA Antigen
Became inhibitory effect, it is called ELISA inhibition method.
Tissue engineering medical device products
Animal-derived scaffold material residues α-Gal antigen test
1 Scope
This standard gives the tissue engineering medical equipment products used in the preparation of scaffold material animal-derived biomaterial residual α-Gal antigen
Quantitative detection method.
This standard applies to the preparation of tissue engineering medical equipment products scaffolds of various animal-derived biological materials or derivatives
α-Gal antigen test.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.20 Biological evaluation of medical devices - Part 20 - Principles and methods of immunotoxicological testing of medical devices
(GB/T 16886.20-2015, ISO /T S10993-20.2006, IDT)
YY/T 0606.25 Tissue engineering medical products - Part 25. Determination of DNA residue of animal-derived biomaterials - Fluorescent staining
Color method
3 Terms and definitions
GB/T 16886.20 and YY/T 0606.25 defined terms and definitions apply to this document.
4 reagents and equipment
4.1 Reagents
Reagents included.
a) Phosphate buffered saline (pH 7.4);
b) carbonate buffer (pH 9.5);
c) Commercially available α-GalEpitope (Galα1-3Galβ1-4GlcNAc-R), mAb (M86), aliquoted and stored at -20 ° C;
d) commercially available Galα1-3gal-BSA (3 atomspacer, referred to as Gal-BSA), dissolved in deionized water, stored at -20 ℃ after storage
spare;
e) Horseradish enzyme-labeled goat anti-mouse secondary antibody (IgM-HRP);
f) TMB (3,3 ', 5,5'-Tetramethylbenzidine) color developing solution;
g) Serum albumin;
h) Lysates (commercial products) whose main components include 50 mmol/L Tris, pH 7.4,
150 mmol/L sodium chloride (NaCl), 1% (volume fraction) Triton X-100, 1%
Concentration) sodium deoxycholate, 0.1% (mass concentration) sodium lauryl sulfate (SDS), sodium orthovanadate
sodiumorthovanadate, sodiumfluoride, ethylenediaminetetraacetic acid (EDTA), leupeptine