生物技术平台 Biotechnology Platform
生物技术平台 Biotechnology Platform

药学研究平台

Pharmaceutical Research Platform

药物安全评价研究中心

Center for Drug Safety Evaluation and Research

临床医学平台

Clinical Medicine Platform

生物技术平台

Biotechnology Platform

服务与整体解决方案

Service and Overall Solutions
生物技术平台 Biotechnology Platform

Biotechnology

Platform

概览 Overview

美莱德生物技术平台建立了符合GCP标准的生物样本分析实验室，支持临床研究（BE，I-IV期），提供涵盖化学药、治疗性生物制品、预防性生物制品临床试验中生物样本分析服务。
生物技术平台已建立完善的质量管理体系，对临床试验生物样本分析全流程进行监管。可提供满足临床试验要求的分析方法学开发、验证和样本检测服务。

The Biotechnology platform has established a GLP/GCP compliant biometric analysis laboratory to support drug screening and development, preclinical and clinical studies (BE, PHASE I-IV), providing biometric analysis services throughout the life cycle of drugs.

The laboratory is equipped with electronic access control, video monitoring, temperature and humidity monitoring throughout the experiment, and yellow light lighting. With a group of professional detection and analysis team, the project experience is rich.

服务范围 Scope of Services
配体结合
Ligand Binding

· 基于抗原抗体结合反应，利用多种技术平台如全自动化学发光平台、ELISA平台（吸光度、荧光、化学发光）、MSD（超敏多因子电化学发光）平台、全自动生化分析平台进行临床生物样本或Biomarker的分析检测。
·满足临床试验法规要求的治疗和预防性生物制品的PK、PD、免疫原性（包括ADA）分析研究方法开发、验证和样本检测。
· 满足临床试验法规要求的预防性生物制品的免疫原性研究（结合抗体）分析方法开发、验证和样本检测。

· Based on the antigen-antibody binding reaction, using a variety of technical means (ELISA, MSD, chemiluminescence, biochemical reactions, etc.), for clinical biological samples or Biomarker analysis and detection.
· Development, validation and sample testing of pharmacokinetics, immunogenicity (ADA) analysis and detection methods for therapeutic biological products that meet the requirements of clinical trials.
· Meet the "Guiding Principles for Vaccine Clinical Antibody Analysis (Draft for Comment)" (2020.10) for the development, validation and sample testing of combined antibody analysis.
· Use MSD to develop, validate and sample test methods for multi-factor detection of therapeutic and preventive biological products.
质谱
Mass Spectrometry

· 液相色谱串联质谱（LC-MS/MS）可进行临床生物样本的分析检测，包括各类小分子、大分子化合物及Biomarker、复杂代谢物分析等，主要进行方法学开发和验证、临床前及临床试验样本检测，分析报告撰写的服务。
· 满足临床试验要求的化学药品/多肽药物的药代动力学分析检测方法学开发、验证和样本检测。
· 满足临床试验要求的内源性Biomarker的药代动力学分析检测方法学开发、验证和样本检测。

· Liquid chromatography tandem mass spectrometry (LC-MS/MS) can be used for the analysis and detection of clinical biological samples, including various small molecules, macromolecular compounds and Biomarker, complex metabolite analysis, etc., mainly for methodological development and verification, pre-clinical And clinical trial sample testing, analysis report writing services.
· Development, verification and sample testing of pharmacokinetic analysis and testing methods for chemical drugs/peptide drugs that meet the requirements of clinical trials.
· The pharmacokinetic analysis and detection methodology development, validation and sample testing of endogenous Biomarker that meet the requirements of clinical trials.
病原微生物检测
Pathogen Detection

· 针对病原微生物进行分离、培养、亚型鉴定、细菌/真菌改造、质粒构建、假病毒制备等工作，高滴度病毒培养达到10的11次方 数量级（VSV）。
· 满足《疫苗临床抗体分析指导原则（征求意见稿）》（2020.10）假病毒中和抗体方法学开发、验证以及高通量检测。

· Isolation, culture, subtype identification, bacterial/fungal modification, plasmid construction, pseudovirus preparation, etc. for pathogenic microorganisms. High-titer virus culture reaches the order of 10 to the 11th power (VSV).
· Meet the "Guiding Principles of Vaccine Clinical Antibody Analysis (Draft for Comment)" (2020.10) methodological development, verification and high-throughput testing of pseudovirus neutralizing antibodies.
细胞免疫检测
Cellular Immunoassay

· 利用流式细胞术（FCM）和酶联免疫斑点（ELISPOT）技术开展细胞免疫评价工作。
· 满足疫苗临床样本检测的胞内因子的流式细胞术方法学开发、验证以及高通量检测。
· 满足疫苗临床样本检测的细胞因子的Elispot方法学开发、验证以及高通量检测。
· 细胞因子：INF-γ、IL-2、IL-4、IL-6等。

· Use flow cytometry (FCM) and enzyme-linked immunospot (ELISPOT) technology to carry out cellular immune evaluation.
· Flow cytometry methodology development, verification and high-throughput testing of intracellular factors that meet the requirements of vaccine clinical sample testing.
· Elispot methodology development, validation and high-throughput testing of cytokines that meet the requirements of vaccine clinical sample testing.
· Cytokines: INF-γ, IL-2, IL-4, IL-6, etc.
细胞及微生物
Cells and Microorganisms

细胞培养、生物制品、细胞增殖与毒性、基因过表达/沉默、细胞转移、细胞稳定株构建、工程菌株构建及建库、微生物发酵工艺开发、纯化工艺开发。

Cell culture, biological products, cell proliferation and toxicity, gene overexpression/silencing, cell transfer, cell stable strain construction, engineering strain construction and library construction, microbial fermentation process development, purification process development.