YY/T 1849-2022 in English

VALID

Recombinant collagen protein

Issued on:2022-01-13
Implemented on:2022-08-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	YY/T 1849-2022
Document status:	VALID
Title in English:	Recombinant collagen protein
Title in Chinese:	重组胶原蛋白
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2022-01-13
Implemented on:	2022-08-01
Professional Classification:	YY-Pharmaceutics
Related Keywords:	natural collagen recombinant collagen key recombinant collagen recombinant collagen protein introduction technical background recombinant products collagen products
Related Topics:	collagen coating protein bars the protein protein interaction collagen denaturation light sensitive protein protein recombine collagen coating Recombinant protein non-denatured protein collagen denaturation After protein denaturation page+protein protein system collagen denaturation many proteins protein sds protein histone protein cause collagen denaturation Egg collagen secretion Protein denaturation instrument protein structure collagen dish non-denatured collagen cell protein protein hplc protease chytrid protein dumas protein Collagen protein gel histone Hexaporin degree of collagen denaturation denatured collagen Collagen preparation collagen, denatured protein principle protein principle How much collagen protein action Protein+ denaturation of collagen protein gel non-denatured collagen protein stealth denatured non-denatured collagen protein expression protein Collagen Electrophoresis Recombinant protein activity Protein-like effect amount of protein Microhistone protein except sds cellular collagen histo-like protein How long does collagen protein preserve histone protein + instant Collagen Electrophoresis Non-denatured + Collagen protein electrophoresis protein Collagen Electrophoresis protein black protein structure protein filler Recombinant protein activity microgram+protein+ ethanol collagen Recombinant protein activity denatured collagen protein group protein organization flow membrane protein protein pole protein spline hypothetical protein Collagen during electrophoresis Colloidal gold protein protein+sds Collagen protein electrophoresis Collagen+ Electrophoresis total histone tissue block protein Collagen Content Fast Collagen outer membrane protein protein hplc membrane protein and total protein Total and Membrane Proteins protein + sample volume Activity of recombinant protein protein filler stock solution stock solution protein instant nictitating membrane protein mantle protein Collagen, in ethanol protein digest protein protein + self egg white collagen + protein protein solution volume protein + centrifugation Hydrophobin+ protein hand protein collagen Hepatin thermal denaturation of collagen Protein denaturation instrument protein sample amount non-denaturing protein Protein meter function denaturation of collagen denatured collagen non-gelling protein denatured collagen Membrane protein flow cytometry protein standard dish The role of protein protein + principle protein gel electrophoresis non-denatured type II collagen spectral protein rat tail collagen protein gelation Amidin non-denatured/ protein molecular protein protein+sds protein gel food t9 protein flow + membrane protein transient protein recombinant protein transfer protein total membrane protein collagen-like treatment Glycoprotein Histone acylation protein wash proteome kurtosis brain protein Recombinant protein 5 types of histones collagen denaturation Collagen preparation rat tail collagen protein principle protein + gel Histone protein protein principle opal protein gel electrophoresis protein gel recipe protein eight Collagen content time molecule protein how much collagen kurtosis protein principle Histone+ Recombinant protein is non-toxic self protein Collagen content protein of the week Histone class 5 gelatin by collagen albumin bismuth Electron Microscopy Collagen recombinant human protein near shore protein protein time protein component 3 collagen+ protein from protein recombination non-collagenous glycoprotein collagen glycoprotein Principle of protein content neuren protein ketone protease Collagenase Collagen Concentration protein principle collagen mtt body protein Amida protein protein cell outer membrane protein Protein Assay Principle protein film analyzer collagen glycoprotein Non-collagen Glycoprotein+ Hey protein recombinant protein+ protein cluster Collagen content Collagen Cardiovascular collagen dsc Positive protein After collagen denaturation protein pcr porin protein auto protein-like apparatus Guanidine nictitating membrane protein how membrane proteins collagen food Collagen collagen dsc Cyanogen Bromide Collagen After collagen denaturation Colloidal gold + protein protein sponge How Collagen Denatures protein gel analyzer Type I Collagen Electrophoresis Cyanogen Bromide + Collagen electrophoresis collagen protein water soluble protein laboratory recombinant protein protein colloidal gold method porin collagen jelly Membrane-like Collagen after thermal denaturation Veteran Proteome Collagen Lab coated collagen quality protein thermal denaturation of collagen light sensitive protein protein suspension protein time sds pcr protein conjugated protein Guanidine + protein protein component method Protein Electrophoresis+Gel+ high-efficiency albumin manganese protein protein version extrinsic protein collagen cause manganese protein membrane protein hydrophobic gel protein technology visceral collagen gel electrophoresis protein gel electrophoresis protein Gel electrophoresis + protein target protein Photoprotein protein component brain protein autoprotein protein engineering protein component Photoprotein crude protein and protein collagen sponge related protein Protein Assay Principle Principle of protein machine Photosensitive + protein domestic collagen Histones are made of what hydrophobin crude protein protein engineering Glycoproteins and Proteins bird protein Protein Gel Identification bovine collagen protein spectrum near shore protein medium density protein ftir collagen collagen breakdown denatured protein non-denatured protein downstream protein collagen tube Chromatographic Collagen Determination of collagen content Collagenase III Protein mantle Membrane-like protein glycoprotein type collagenase foods rich in collagen internal protein Membrane protein and total protein collagenase protein upstream protein a frozen tissue protein Oriental Marine Collagen double protein outer membrane protein crude protein + protein Marine Collagen protein cell h1 histone Type II Collagen flow protein gluten protein collagen upstream protein microgram protein Type 123 Collagen collagen hydrogel protein peak cause Collagen Elisa u6 protein unnatural collagen American Collagen Peripherin protein time recombinant protein peptide long-term histone flow membrane protein Gel protein method Protein remover principle Principle of protein sds protein Membrane protein flow cytometry Collagen Primary Cells protein membrane segment protein double strips Specific Protein Meter Principle Total Protein Principle why recombinant protein protein removal membrane protein colloid protein invariance protein+sds+ protein nitrogen and protein microalbumin Collagen detection protein pros and cons protein gel separation Protein Assay Principle Crude protein principle Protein UV principle prealbumin 16 r2 protein a class of proteins Action protein Recombinant and Active Proteins protein glue sheet Collagen detection g1 phase histone collagen plug collagenase type II artificial protein centrosomal protein proteome Collagen grams Microalbumin+ protein boil how much collagen breaks down protein and crude protein Protein + Equipment albumin method white+ Proteome+ Thirteen Five+ protein standard protein pore protein domain protein branch reverse protein s6 protein sds and protein Crude Protein and True Protein protein basic protein total membrane protein Annexin Undenatured Type II Collagen protein in sludge Membrane protein abnormalities collagen breakdown Recombinant Protein Laboratory non-collagen protein four histones True and Crude Protein UV Collagen instrument protein Collagen is polyprotein processing protein + properties Determination of protein principle protein water effect Membrane protein double American Collagen cell protein Protein Assay Principle How to detect collagen protein ladder Helicin triple milk protein protein colloid Grain Collagen recombinant human collagen Collagen Reconstitution moesin normal collagen Europium-labeled protein 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? Collagen Analysis How much collagen is used collagen belly Collagen Autoimmunity Collagen 4 yuan hand protein protein gel crude protein and total protein Microhistone Tahara New Collagen a histone protein glue sheet animal albumin Collagen Purity collagen grains protein gel method Membrane protein dumas protein assay principle malignant protein Complexin crude protein and protein protein and crude protein protein coat histone special protein hplc Collagen Profile Protein Heart Chips protein UV protein molecular weight protein protein molecular weight State heavy reorganization Histone 3 Albumin removal protein specificity Specific Protein Meter Principle recombinant collagen protein sponge Zebrafish proteome Principles of protein purification With 4.1 protein and adducin protein Protein does not hang on the column Principles of protein dialysis Protein cross-linking Proteomic SP3 method conductive protein Chemical denaturation of collagen Collagen physical and chemical properties The principle of acidic dissolution of collagen Urinary albumin 13.9 Running protein glue chromosomal non-histone structural proteins aquaporin asns protein function gst protein column H3 histone internal reference HEI10 protein NH3 protein tag Protein collection RIPA Rac1 membrane protein SP3 proteome TaCPK5 protein unitport protein official website wb protein denaturation melanoma proteome Chengdu Proteome protein altimeter Protein gel strip Principles of protein staining Collagen decomposition temperature Collagen sponge electrophoresis collagen hydrogel acetonitrile protein total protein and crude protein Histone H4 function BIAs proteins cox2 protein band CPT1A protein function Echdc1 protein LCAD protein pet28a protein PSD93 protein SR family proteins Reasons why WB protein gel does not gel Fibrin and globulin Vaccine protein glue Protein input function thbs1 protein function electroporation protein repressor protein Proteome NCBI MAMLD1 protein function Rec A protein Yu Xiaobo proteome protein imbalance cre-loxp recombination principle protein separation gel Protein electrophoresis gel recovery TNFa protein is a secreted protein Recombinant protein endotoxin MRM protein cost Recombinant protein dissolution time protein electrophoresis non-reducing dusp4 protein fis1 protein NICD protein p21 protein function r globulin heavy chain Collagen industry Collagen modification methods Collagen content detection Collagen content detection Recombinant collagen quality Collagen extraction method multiplex proteomic approach Collagen dressing patch Recombinant collagen transdermal absorption medical device collagen protein probe Collagen cross-linking method Collagen Concentration Method Recombinant collagen raw material quality Methods for recombinant protein expression Mucin industry Collagen cross-linking method yy/t 1849-2022 yy/t1849-2022 yy/t1849 yy/t 1849

本文件规定了重组胶原蛋白的质量控制要求、检测指标及其检测方法等。本文件适用于作为医疗器械原材料的重组胶原蛋白的质量控制。

Introduction

Technical background and evolution of standards

As the first pharmaceutical industry standard specifically for recombinant collagen, YY/T 1849-2022 fills the standard gap in the application of genetically engineered collagen products in medical devices. This standard integrates the requirements of the general introduction to human recombinant DNA protein products in the Pharmacopoeia of the People's Republic of China and the product series standards for tissue engineering medical devices, reflecting the following technological evolution:

Shift from traditional tissue extraction of collagen to preparation using genetic recombination technology
Establishment of a multidimensional analytical method for triple helix structure confirmation
Introduction of mass spectrometry technology for characteristic peptide quantification

Core quality control system

Control dimensions	Natural collagen	Recombinant collagen	Key differences
Structure confirmation	Triple helix structure verification	Additional verification of gene sequence matching required	Recombinant products may lack natural conformation
Impurity Control	Animal Virus Risk	Host Protein/DNA Residues	Expression System Determines Differences in Impurity Spectrum
Biological Function	Abundant Empirical Data	Need to Establish a New Evaluation System	The Function of Recombinant Products May Change

Key Implementation Points for Key Testing Items

5.7 Structural Characterization Case

For the verification of triple helix structure, the standard recommends the use of a combined analysis of Circular Dichroism (CD), Differential Scanning Calorimetry (DSC) and Protease Sensitivity Test:

The CD spectrum should have a characteristic positive peak at 221nm
DSC detection depolymerization temperature must be consistent with the reference product
The difference in trypsin digestion rate should be ≤15%

Implementation recommendations and risk control

Based on the standard requirements, manufacturers should pay special attention to:

Expression system selection: Escherichia coli expression needs to focus on endotoxin control, and eukaryotic systems need to verify glycosylation modification
Reference product establishment: It is recommended to freeze ≥3 batches of representative stock solutions as physical and chemical references
Immunogenicity assessment: New recombinant sequences must undergo immunotoxicology studies as required by GB/T 16886.20

More samples: JGJ 94-2008 QC/T 942-2021 GB 50021-2001(2009)

Sample only — not a preview of YY/T 1849-2022

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