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广东省高水平新型研发机构
State Key Laboratory of Ophthalmology (Research Center for Non clinical Evaluation of Ophthalmic Drugs)
Key Laboratory of Non Clinical Evaluation of Drugs in Guangdong Province
炎症与免疫相关疾病教育部基础研究创新中心
创新药物评价与研究广东省工程研究中心
Guangdong Innovative Drug Evaluation and Research Engineering Technology Research Center
Guangdong Provincial Engineering Technology Research Center for Ophthalmic Drug Creation and Evaluation
One stop public service platform for research, development and evaluation of cell and gene therapy drugs in Guangdong-Hong Kong-Macao Greater Bay Area
Non clinical Evaluation Center for Traditional Chinese Medicine, National Research Center for Modernization of Traditional Chinese Medicine
广东省企业技术中心
Key technology platform for research and evaluation of chiral drugs
Innovative drug research and molecular imaging technology and product research technology platform
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Key technology platform for pharmacokinetics research
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Areas of Strength in Evaluation and Research
Ophthalmic drugs
Cell And Gene Therapy Products
Pediatric medicine
Traditional Chinese Medicine
Vaccines And Anti-Infective Drugs
Topical Preparation For Skin
Inhalation Preparations
Dependence And Psychiatric Drug Evaluation Platform
Vaccines And Anti-Infective Drugs
莱恩医药拥有
抗感染药物研究与评价工程技术研究中心
,在抗病毒方面,已建立多种流感病毒、腺病毒、合胞病毒等的非临床评价方法;在抗细菌方面,细菌库内已拥有400多种常见细菌并针对其中大部分建立了体内外的药效评价方法;此外,诸如抗呼吸道感染方面也是已拥有多种动物模型。同时我们还拥有面积超过800平方米的P2实验室,实验室包含了BSL-2实验室、加强型BSL-2实验室以及ABSL-2实验室。
特色研究
1、抗病毒感染体内外药效学评价:莱恩医药已建立多种流感病毒、腺病毒,合胞病毒,仙台病毒、疱疹病毒等体外药效评价方法,可通过CPE、空斑法、MTT、血凝抑制、中和抗体等评价药物和疫苗体外抗病毒效果。体内已建立流感、合胞病毒、手足口病、疱疹病毒等多种不同途径病毒感染的动物模型,模型均经过验证,符合新药评价要求。
2、抗细菌感染体内外药效学评价:莱恩医药已建立结核分枝杆菌、肺炎克雷伯菌、大肠埃希菌、铜绿假单胞菌、流感嗜血杆菌、鲍曼不动杆菌、卡他莫拉菌、肺炎链球菌、化脓链球菌、金黄色葡萄球菌等常见感染细菌的体外药效评价方法,并建立多种不同途径细菌感染的动物模型,模型均经过验证,符合新药评价要求。
3、抗呼吸道感染的药效学评价:抗流感、抗合胞病毒、抗结核杆菌、手足口病等动物模型。
4、新型预防性疫苗的非临床安全性评价:对减毒灭活疫苗、腺病毒疫苗、痘苗疫苗、mRNA疫苗、重组蛋白疫苗、纳米疫苗等类型预防性疫苗进行符合生物安全的有效性和安全性评价研究。
技术实力
按GLP要求建立和验证了疫苗与抗感染药物的各类检测技术,并顺利通过监管部门的考核认证。
配备相应检测仪器设备
研究经验
流感模型
流感模型(雪貂模型机制)
新冠病毒感染模型:
已完成超过20个新冠疫苗、涉及毒株包括WT、Delta、Omicron及其变种等。
合胞病毒感染模型:
已完成6个合胞病毒感染治疗药物评价
EV71感染手足口病模型:
已完成4个感染治疗药物评价
临床耐药菌感染模型:
已完成超过20个细菌感染治疗药物评价
服务成果
近几年完成超过30个抗感染药物非临床评价试验,已获临床批件近20个,包括7个1类新药;
已支持多个不同类型的疫苗获批临床。
ABSL-2级生物安全实验室内景
BSL-2+级生物安全实验室内景