商铺首页
公司详情
产品陈列室
联系方式
基本信息
企业名称
南京明捷生物医药检测有限公司
企业地址
江苏省南京市南京江北新区新锦湖路3-1号中丹生态生命科学产业园C栋1、3、6层
成立日期
2016
企业规模(人)
100至149
年销售额(USD)
不愿意公开
企业简介
明捷医药(药明康德控股子公司) 作为一家国际化的药物质量研究服务提供商,致力于构建符合全球药政法规(包括FDA、EMA、NMPA等)的一体化药物质量研究技术平台。公司持续引领行业标准,助力客户加速药物研发与商业化进程。公司总部位于南京,在南京江北新区和上海浦东新区设有总面积超8,200平方米的CNAS认证实验室。2023年,两地实验室均成功通过美国FDA现场检查,并多次顺利通过中国CFDI核查,彰显了国际化的质量管理体系和卓越的合规运营能力。凭借全面的技术平台和丰富的项目经验,明捷医药已为全球2,500+家制药及生物技术企业提供涵盖药学研究、药物分析及测试服务的高效解决方案,累计交付项目10,000+。我们的服务能力覆盖:·         小分子药物(创新药、仿制药、原料药)·         生物药及复杂制剂(多肽、生化药、抗体偶联药物)·         药用辅料与包装材料·         细胞与基因治疗(CGT)产品·         医疗器械及药械组合产品从早期研发,注册申报到产品上市和上市后变更,我们为客户提供全生命周期的质量研究支持,明捷医药始终秉持"以客户需求为中心"的服务理念,通过模块化技术平台和定制化解决方案,助力客户突破技术壁垒,缩短研发进程,实现产品全球市场战略布局。
主要竞争优势
经验丰富的研发人员,产品线丰富,接受买家的规格要求,良好的信誉,优质服务
邮政编码
211151
贸易信息
业务类型
服务商
主要销售市场
中国,北美洲,中/南美洲,西欧,东欧,大洋洲,中东,非洲
主营产品类别
合同外包、定制服务及咨询
交付方式
与客户约定
合同定制与外包服务
CRO
支付方式
对公
参展信息
主营产品
Innovative Drug Pharmaceutical Research;Improved New Drug Pharmaceutical Research;Generic Drug Pharmaceutical Research;Starting Material Quality Research;Intermediate Quality Research;Consistency Evaluation of Generic Drugs;Pharmaceutical Packaging Material Filing;Packaging Material Testing;YBB Testing;Packaging Material Identification;Drug Master File (DMF) Filing for Pharmaceutical Packaging Materials;Medical Device Filing;Combination Product Filing;Combination Product Research;Packaging Material Compatibility E&L Research;Process Component Compatibility;Drug Delivery Device Compatibility;Filter Cartridge Validation;Container Closure Integrity Testing (CCIT);Laser Drilling;Vacuum Decay Method;Pressure Decay Method;Helium Mass Spectrometry;High Voltage Discharge Method;Dye Penetration Test;Microbial Challenge and Statistical Data Analysis;Microbial Testing;Microbial Limit;Bacteriostatic Effectiveness;Bacterial Endotoxin;Disinfectant Cleaning Validation;Bacterial Retention;Antibiotic Potency;Pharmaceutical Packaging Material Filing;Water System Validation;Air Conditioning System Validation;Process Gas Validation;Crystal Form Research;Crystal Form Qualification;Crystal Form Quantification;Crystal Form Screening;Salt Form Screening;Impurity Crystal Research;Crystal Form of Active Pharmaceutical Ingredient (API) in Formulations;Impurity Crystal Quantification;Active Pharmaceutical Ingredient (API) Quality Research;Establishment of API Quality Standards;API Structure Confirmation;Intermediate Structure Confirmation;Known Impurity Structure Confirmation;Unknown Impurity Structure Identification;Molecular Weight;Elemental Analysis;Nuclear Magnetic Resonance (NMR);NMR Quantitative Research;Deuterium Incorporation Rate;NMR Carbon Spectrum;NMR Hydrogen Spectrum;NMR C-H 2D Spectrum;NMR Fluorine Spectrum;NMR DEPT Spectrum;Reference Substance Customization;Reference Substance Separation and Purification;Impurity Separation and Purification;Main Component Separation;Protein Impurity Separation;Protein Purification;Particle Size Distribution;Dry Particle Size Analysis;Wet Particle Size Analysis;Powder Property Research;Identification and Distribution of Raw Materials and Excipients in Formulations;Crystal Form and Particle Size of API in Formulations;Coating Layer Composition and Thickness Research;Nanoliposome Characterization;Liposome Particle Size Distribution;Liposome Zeta Potential Characterization Analysis;Liposome Lamellar Characterization Analysis;Liposome Encapsulation Efficiency Characterization Analysis;Liposome Morphology Characterization Analysis;Insoluble Particle Identification;Visible Foreign Matter Identification Analysis;Insoluble Particle Identification Analysis;Visible Foreign Matter Traceability Research;Insoluble Particle Traceability Research;Software Assessment of Genotoxic Impurities;Risk Assessment of Genotoxic Impurities;Research on Genotoxic Impurities;Genotoxic Impurity Profile and Classification;Toxicological Data Query and Impurity Limit Calculation for Genotoxic Impurities;Development of Control Strategies for Genotoxic Impurities;Risk Assessment Report Writing for Genotoxic Impurities;Software Assessment of Nitrosamine Impurities;Risk Assessment of Nitrosamine Impurities;Research on Nitrosamine Impurities;Investigation of Sources and Formation Mechanisms of Nitrosamine Impurities;Development of Control Strategies for Nitrosamine Impurities;Risk Assessment Report Writing for Nitrosamine Impurities;Precursor Impurity Screening: Nitrite and Small Molecule Secondary Amine Impurities;Research on Trace Impurities in Drugs;Research on Elemental Impurities;7 Elements for Oral/Transdermal Administration;10 Elements for Injection Drugs;Process Additives such as Pd, Mo, Ag, etc.;High-Risk Elements such as Si, W, Os, etc.;Biological Drug Process Residuals;Defoamer Residuals;Transfection Agent Residuals;Surfactant Residuals;Residual Solvents;Acid Radical Ion Detection;Metal Ion Detection;Analytical Method Development;Analytical Method Validation;Analytical Method Testing;Analytical Method Transfer;Analytical Method Defect Investigation;Analytical Method Optimization;Analytical Method Comparison and Review;Development, Validation, and Testing of Analytical Methods for Related Substances;Development, Validation, and Testing of Analytical Methods for Chiral Isomers;Development, Validation, and Testing of Analytical Methods for Residual Solvents;Development, Validation, and Testing of Analytical Methods for Elemental Impurities;Development, Validation, and Testing of Analytical Methods for Polymeric Impurities;Development, Validation, and Testing of Analytical Methods for Genotoxic Impurities;Development, Validation, and Testing of Analytical Methods for Nitrosamine Impurities;Development, Validation, and Testing of Analytical Methods for Protein Residuals;Development, Validation, and Testing of Analytical Methods for Enzyme Residuals;Development, Validation, and Testing of Analytical Methods for Nucleic Acid Residuals;Development, Validation, and Testing of Analytical Methods for Lipid Residuals;Development, Validation, and Testing of Analytical Methods for Carbohydrate Residuals;Development, Validation, and Testing of Analytical Methods for Assay Determination;Development, Validation, and Testing of Analytical Methods for Potency Determination;Development, Validation, and Testing of Analytical Methods for Antioxidants;Development, Validation, and Testing of Analytical Methods for Bacteriostatic Agents;API Filing;API DMF Filing;API CEP Filing;API Process Changes;Comprehensive Impurity Research on APIs;Pharmaceutical Excipient Filing;Pharmaceutical Excipient Registration and Filing;Pharmaceutical Excipient Changes;Establishment of Excipient Quality Standards;Pharmacopoeia Testing;Chinese Pharmacopoeia Testing;United States Pharmacopoeia Testing;European Pharmacopoeia Testing;Formulation Development and In Vitro Evaluation;Development and Quality Research of Injection Formulations;Development and Quality Research of Liquid Oral Formulations;Development and Quality Research of Semi-Solid Formulations;Development and Quality Research of Oral Solid Formulations;Development and Quality Research of Animal Formulations;Development and Quality Research of Amorphous Solid Dispersion (ASD) Formulations for Poorly Soluble Drugs;Drug Dissolution;Drug In Vitro Release;Transdermal Research;In Vitro Evaluation of Transdermal Formulations;Drug Solubility Research;Drug Permeability Research;Drug In Vitro Binding;In Vitro Phosphate Balance and Kinetic Experiments;In Vitro Bile Salt Balance and Kinetic Experiments;BSA Protein Binding Experiments;Pepsin Binding Experiments;Cyclodextrin Inclusion Research;Cyclodextrin Drug Inclusion Ratio;Comparison of Binding Constants;Inclusion Isotherm Research;Inclusion Dilution Curve Research;Inclusion and Release Curve Research;Structural Characterization of Biologics;Protein Structural Characterization;Protein Molecular Weight;Polysaccharide Molecular Weight;Polymer Molecular Weight;Intact Protein Molecular Weight;Deglycosylated Protein Molecular Weight;Reduced Molecular Weight;Deglycosylated and Reduced Molecular Weight;Ides Subunit Molecular Weight;Peptide Mapping;Peptide Coverage;Amino-terminal Sequence;Protein Amino Acid Composition Analysis;Protein De Novo Sequencing;N-terminal Sequencing;C-terminal Sequencing;Amino Acid Post-translational Modifications;Disulfide Bond Mispairing;Disulfide Bond Confirmation;Glycosylation Modifications;O-linked Glycosylation Sites;N-linked Glycosylation Sites;Free N-glycan Analysis;Aggregate Analysis;Nucleic Acid Molecular Weight;Nucleic Acid Sequence Analysis;mRNA Drug Capping Rate Analysis;mRNA Drug Poly A Tail Length Analysis;Structural Confirmation of Peptide Drugs;Peptide Molecular Weight;Peptide Sequence;Amino Acid Composition Analysis of Peptides;Identification of Peptide-related Impurities;Identification of Missing Peptides;Identification of Inserted Peptides;Identification of Missorted Peptides;Identification of Broken Peptides;Identification of Epimeric Peptides;Identification of Modified Peptides with Substituted Leu/Ile;Identification of Peptide-related Impurities with Modified Side Chains;Identification of Amino-acetylated Peptides;Identification of Polymeric Impurities in Peptides;Quality Research on ADC Drugs;Structural Confirmation of ADC Drugs;DAR Value of ADC Drugs;Distribution Analysis of ADC Drugs;Quality Research on Oligonucleotide Drugs;Quality Research on mRNA Drugs;Stability Research;Research on Factors Affecting Drug Stability;Long-term Accelerated Stability Research on Drugs;Stability Research During Drug Use;Compatibility Stability Research;Stability Research After Opening Multi-dose Packaging;Thermal Cycling Research;Freeze-thaw Cycling Research;Reverse Engineering Analysis;Analysis of Excipient Types and Contents in Reference Formulations;Analysis of Inorganic Salt Excipients in Reference Formulations;Analysis of Sugar Alcohol Excipients in Reference Formulations;Analysis of Organic Acid Excipients in Reference Formulations;Analysis of Surfactant Excipients in Reference Formulations;Analysis of Cellulose Derivative Excipients in Reference Formulations;Composition and Dosage Analysis of Formulation Excipients;Screening of Polymer Excipient Types;Quality Research on Functional Excipients;Research on Polymeric Impurities in β-Lactam Antibiotics;Research on Polymeric Impurities in Penicillin;Research on Polymeric Impurities in Cephalosporins;Clinical Compatibility Research;Raw Material Inspection;Physical Properties of Raw Materials;Appearance;Solubility;Relative Density;Melting Point;Specific Rotation;Viscosity;Freezing Point;Identification of Raw Materials;Infrared Spectroscopy;Ultraviolet Spectroscopy;Thin Layer Chromatography;pH Value (Acidity and Alkalinity);Solution Clarity and Color;Conductivity;Refractive Index;Light Transmittance;Optical Activity;Absorption Coefficient;Chloride Detection;Sulfate Detection;Sulfite Detection;Non-volatile Matter Detection;Carbonizable Substance Detection;Ammonium Salt Detection;Iron Salt Detection;Reducing Sugar Detection;Ethylene Oxide and Dioxane Detection;Free Glycerol Detection;Fatty Acid Composition and Identification Detection;Ethylene Glycol Detection;Diethylene Glycol Detection;Triethylene Glycol Detection;Average Degree of Substitution;β-Cyclodextrin Detection;Loss on Drying;Moisture;Residue on ignition;Elemental analysis;Arsenic salt detection;Heavy metal detection;Acid-base titration;pKa (acid dissociation constant);LogP (partition coefficient);Liquid chromatography;Gas chromatography;Liquid chromatography-mass spectrometry (LC-MS);Gas chromatography-mass spectrometry (GC-MS);Thermogravimetric analysis (TGA);Differential scanning calorimetry (DSC);X-ray diffraction (XRD);Raman spectroscopy;Scanning electron microscopy (SEM);Polarized Light Microscopy (PLM);Dynamic Vapor Sorption (DVS);Dynamic Light Scattering (DLS)
参展展会
第二十三届世界制药原料中国展
展会时间
2025-03-06至2025-07-31
展位号
E2B47
展品分类
CMO & CRO;Biotech
参展信息
×