YY/T 1888-2023 in English

VALID

Recombinant humanized collagen protein

Issued on:2023-01-18
Implemented on:2023-07-20
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $280.00
$272.00

Standard No:	YY/T 1888-2023
Document status:	VALID
Title in English:	Recombinant humanized collagen protein
Title in Chinese:	重组人源化胶原蛋白
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2023-01-18
Implemented on:	2023-07-20
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	recombinant collagen collagen protein introduction standard background genetic engineering collagen materials human type iii collagen lc-ms multiple enzyme digestion verification impurity controlhost protein
Related Topics:	protein bars the protein protein interaction protein recombine Recombinant protein page+protein protein system many proteins protein sds protein histone protein cause collagen denaturation collagen dish Peptide Mapping non-denatured collagen long-acting protein dumas protein Collagen protein gel degree of collagen denaturation denatured collagen protein principle How much collagen Protein+ denaturation of collagen protein gel non-denatured collagen protein stealth denatured non-denatured collagen Collagen Electrophoresis Recombinant protein activity Collagen Mineralization How long does collagen protein preserve protein + instant Collagen Electrophoresis Non-denatured + Collagen Collagen Electrophoresis Recombinant protein activity ethanol collagen Recombinant protein activity Collagen during electrophoresis Colloidal gold protein protein+sds Collagen protein electrophoresis Collagen+ Electrophoresis Collagen Content Fast Collagen Body Temperature Collagen Activity of recombinant protein protein instant Collagen, in ethanol protein digest protein protein + self egg white collagen + protein protein purity protein hand protein collagen Hepatin thermal denaturation of collagen denatured collagen non-gelling protein Peptide Fingerprinting protein + principle non-denatured type II collagen rat tail collagen protein gelation Amidin protein+sds t9 protein collagen-like treatment Histone acylation Foreign protein not expressed protein purity proteome kurtosis brain protein Recombinant protein 5 types of histones rat tail collagen protein + gel Histone protein protein principle opal how much collagen chemical protein kurtosis protein principle Recombinant protein is non-toxic protein of the week biochemical protein albumin bismuth recombinant human protein protein time protein component 3 collagen+ protein from non-collagenous glycoprotein collagen glycoprotein protein ketone artificial protein collagen mtt Amida protein collagen glycoprotein Non-collagen Glycoprotein+ Hey protein protein cluster Collagen Cardiovascular After collagen denaturation protein pcr porin Guanidine collagen food Collagen Cyanogen Bromide Collagen After collagen denaturation Colloidal gold + protein How Collagen Denatures protein gel analyzer Type I Collagen Electrophoresis Cyanogen Bromide + Collagen electrophoresis collagen human protein laboratory recombinant protein protein purity protein colloidal gold method porin chemiluminescent protein Collagen after thermal denaturation Protein Chemistry 11 Veteran Proteome Collagen Lab thermal denaturation of collagen degree of protein acylation Guanidine + protein high-efficiency albumin manganese protein protein version extrinsic protein manganese protein Histone propionylation in vitro gel protein technology visceral collagen target protein Photoprotein protein component Human source brain protein protein purity protein component Humanization Photoprotein artificial protein collagen sponge related protein human collagen Principle of protein machine domestic collagen Histones are made of what Protein Gel Identification human type 1 collagen Chromatographic Collagen Collagenase III type collagenase foods rich in collagen collagenase double protein h1 histone Type II Collagen flow protein gluten protein collagen Type 123 Collagen protein peak cause u6 protein unnatural collagen American Collagen protein item recombinant protein peptide long-term histone Gel protein method Protein remover principle sds protein Specific Protein Meter Principle why recombinant protein protein colloid protein+sds+ Collagen detection protein gel separation Protein Assay Principle Crude protein principle Protein UV principle r2 protein Action protein Recombinant and Active Proteins protein glue sheet Collagen detection g1 phase histone collagenase type II protein digester artificial protein proteome human testoprotein recombinant human Collagen grams Proteome+ Thirteen Five+ protein standard s6 protein Undenatured Type II Collagen human glue collagen breakdown Recombinant Protein Laboratory non-collagen protein four histones UV Collagen Collagen is protein normalization double humanization model protein source Membrane protein double American Collagen How to detect collagen protein ladder chemical source protein colloid Grain Collagen recombinant human collagen Collagen Reconstitution Lowry protein protein colloidal gold r2 collagen starch collagen Collagen exogenous protein polymerizable collagen What is the purity of collagen proteochemical Collagen Sterilization Principle of protein removal Test for Collagen Content collagen membrane protein Is collagen hydrophobic? How much collagen is used collagen belly Collagen 4 yuan protein gel Microhistone human ferritin Tahara New Collagen a histone protein glue sheet protein quantification Collagen Purity collagen grains protein gel method protein alkylation Membrane protein dumas protein assay principle Complexin protein coat histone special Peptide Fingerprinting Collagen Profile human vi collagen State heavy reorganization Histone 3 Albumin removal chemiluminescent protein homologous recombination Specific Protein Meter Principle recombinant collagen Zebrafish proteome Principles of protein purification With 4.1 protein and adducin protein Principles of protein dialysis Proteomic SP3 method Chemical denaturation of collagen Collagen physical and chemical properties The principle of acidic dissolution of collagen How collagenase digests tissue Urinary albumin 13.9 Running protein glue chromosomal non-histone structural proteins H3 histone internal reference HEI10 protein Ni column protein purification SP3 proteome TaCPK5 protein TCAB02422023 Implant-grade recombinant humanized collagen type A NKD1 purified protein Chengdu Proteome Protein gel strip Principles of protein staining Collagen sponge electrophoresis collagen hydrogel Homologous recombination holiday model Histone H4 function BIAs proteins Echdc1 protein LCAD protein pet28a protein PSD93 protein SR family proteins Reasons why WB protein gel does not gel thbs1 protein function repressor protein Unpurified protein Proteome NCBI MAMLD1 protein function Yu Xiaobo proteome cre-loxp recombination principle protein separation gel Protein electrophoresis gel recovery Lithium borohydride protein Recombinant protein dissolution time protein electrophoresis non-reducing dusp4 protein fis1 protein NICD protein r globulin heavy chain Collagen industry Collagen modification methods Collagenase digestion Protein purification methods and principles Collagen content detection Protein normalization Collagen content detection Collagen extraction method multiplex proteomic approach Recombinant collagen transdermal absorption medical device collagen Collagen cross-linking method Standardization of proteomic results Collagen Concentration Method Proteome homogenization methods Recombinant collagen raw material quality chemical protein Methods for recombinant protein expression Collagen cross-linking method Recombinant humanized collagen protein purification yy/t1914-2023 yy 1888-2023 yyt 1888-2023 yy/t1889-2023 Protein gel purification method Protein organization methods Protein purification methods yy/t1876-2023 yy/t1901-2023 yy/t1915-2023 yy/t 1888-2023 yy-t1920-2023 yy/t0469-2023 qb/t 1888-2023 yy/t1867-2023 yy/t1888-2023 yy/t1908-2023 yy/t 0906 2023

本文件规定了重组人源化胶原蛋白的质量控制、技术要求、试验方法、稳定性、生物学评价以及包装、运输和贮存等。
本文件适用于作为医疗器械原材料的不含非人胶原蛋白氨基酸序列的重组人源化胶原蛋白的质量控制。

Introduction

Standard Background and Technology Evolution

YY/T 1888-2023 is my country's first industry standard for recombinant humanized collagen, marking the entry of genetic engineering collagen materials into the standardization stage of medical device applications. This standard is based on the general requirements of YY/T 1849-2022 "Recombinant Collagen" and makes special provisions for humanized characteristics.

Core quality control requirements

Detection dimensions	Key indicators	Technical points
Physical and chemical properties	Purity ≥ 95%	SDS-PAGE and HPLC double verification
Structural characterization	Peptide coverage 100%	LC-MS multiple enzyme digestion verification
Impurity control	Host protein ≤ 0.05%	ELISA specific detection
Advanced structure	CD spectrum characteristic peaks	195nm negative peak/221nm positive peak

Key technological breakthroughs

1. Humanized sequence verification

It is required to provide a complete amino acid sequence comparison certificate, and use the NCBI database for human consistency verification to ensure that there are no non-human sequence fragments. Typical example: Human type III collagen (380G-641G) × 2 represents a repeating structure.

2. Structural characterization system

Establish a four-level detection system:
① Primary structure: mass spectrometry molecular weight (error ±1Da)
② Secondary structure: circular dichroism (CD)
③ Tertiary structure: differential scanning calorimetry (DSC)
④ Crystal structure: X-ray diffraction (resolution ≤3Å)

Implementation suggestions

Key points of production process control

Expression system selection: Differences in residue control standards for E. coli/yeast/CHO cells
Lyophilization process validation: Balance between moisture content and activity retention
Additive management: Amount of cross-linking agent and residue detection method

Biological evaluation strategy

According to the requirements of GB/T 16886.1, special attention should be paid to the following:
• Immunogenicity assessment (GB/T 16886.20)
• Degradation characteristics of long-term implants
• Evaluation limitations caused by species differences

Industry impact analysis

The implementation of this standard will promote the standardized application of recombinant collagen in the following fields:
1. Wound dressings: microbial limit ≤100CFU/g
2. Cosmetic fillers: osmotic pressure 270-360mOsmol/kg
3. Tissue engineering scaffolds: bacterial endotoxin ≤5EU/kg

More samples: DL/T 368-2010 NB/T 47013.2-2015 JC/T 2453-2018

Sample only — not a preview of YY/T 1888-2023

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