关于我们-苏州鲲泰生物科技有限公司

苏州鲲泰生物科技有限公司

KunTai
Introductional

关于鲲泰

苏州鲲泰生物科技有限公司

苏州鲲泰生物科技有限公司，注册资本5000万元，坐落于苏州工业园区生物医药产业园，经营地址位于新平街388号腾飞创新园21幢，是一家从事特色原料药自主研发、中美注册申报、生产以及全球销售一体化的成长性公司，是上市公司富士莱（股票代码：301258）的全资子公司。公司紧跟医药前沿技术，基于生物医药产业发展趋势，建立独立自主的技术研发平台。公司致力于为国内外客户提供符合cGMP的小分子特色原料药为客户提供个性化定制合成和生产服务。

公司全面积极推进寡核苷酸业务团队的搭建及平台建设，已经配置的仪器设备有Mermaid 12合成仪、Dr. Oligo192合成仪、 AKTA Oligosynt合成仪、氨解仪、AKTA Pure 150纯化仪、高压制备液相色谱、中压液相制备色谱、AKTA Flux S切向流超滤系统、生物惰性HPLC，质谱仪如LC-QTOF(1290bio-6545XT)、冻干机等。可以为客户提供OD级，毫克级，克级和公斤级（GMP中试车间在建）的寡核苷酸序列合成服务，以及GalNAc系列递送分子的订制合成及生产服务。

Suzhou Kuntai Biotechnology Co, Ltd.,

Suzhou Kuntai Biotechnology Co., Ltd., with a registered capital of 50 million yuan, is located in Suzhou Industrial Park Biomedical Industrial Park, and its business address is located in Building 21, Ascendas Innovation Park, No. 388, Xinping Street, is a growth company engaged in independent research and development of characteristic APIs, Sino-US registration and application, production and global sales integration, and is a wholly-owned subsidiary of Fujirai (stock code: 301258). The company closely follows the cutting-edge technology of medicine, and establishes an independent technology research and development platform based on the development trend of the biomedical industry. The company is committed to providing cGMP-compliant small molecule characteristic APIs to provide customers with personalized customized synthesis and production services.

The company has fully and actively promoted the construction of oligonucleotide business team and platform construction, and has been equipped with instruments and equipment such as Mermaid 12 synthesizer, Dr. Oligo192 synthesizer, AKTA Oligosynt synthesizer, ammonihydrolysis instrument, AKTA Pure 150 purifier, high-pressure preparative liquid chromatography, medium pressure liquid preparative chromatography, AKTA Flux S tangential flow ultrafiltration system, bioinert HPLC, mass spectrometers such as LC-QTOF ( 1290bio-6545XT), lyophilizer, etc. We can provide customers with OD, mg, gram and kg oligonucleotide sequence synthesis services (GMP pilot plant under construction), as well as GalNAc series delivery molecules customized synthesis and production services.

Equipment And Facilities
Technology Platform

设备设施 / 技术平台

1000m²

公司建有1000㎡的研发实验室

3000余万

投资3000余万元购置先进的仪器设备，
为药物研发工作提供了坚实的硬件基础。

The company has built a 1,000-square-meter R&D laboratory and invested more than 3,000 yuan to purchase advanced instruments and equipment, which provides a solid hardware foundation for drug research and development.

Main Instruments
And Equipment

主要仪器设备

液相色谱仪：

Liquid chromatograph:

Waters Acquity UPLC 超高效液相色谱、Agilent 1260Bio 高效液相色谱仪、Agilent1260高效液相色谱仪、 Thermo Vanquish Core CAD 液相色谱仪

Waters Acquity UPLC Ultra Performance Liquid Chromatography, Agilent 1260Bio HPLC, Agilent1260 HPLC, Thermo Vanquish Core CAD LC

液质联用仪：

LC/MS instrument:

Agilent 1290Bio-6545XT Q-TOF 液质联用系统、Thermo LTQ velos pro 线性离子阱质谱、Agilent 6130 单四极杆质谱

Agilent 1290Bio-6545XT Q-TOF LC/MS system, Thermo LTQ velos pro linear ion trap mass spectrometry, Agilent 6130 single quadrupole mass spectrometry

气相色谱仪：

Gas chromatograph:

Agilent 8890气相色谱仪

Ag ilent 8890 gas chromatograph

核酸合成仪：

Nucleic acid synthesizer:

Dr.oligo 192、MerMade-12、ÄKTA oligosynt™

纯化设备：

Purification equipment:

ÄKTA Pure 150M蛋白纯化系统、ÄKTA Flux S切向流过滤系统

ÄKTA Pure 150M protein purification system, ÄKTA Flux S tangential flow filtration system

紫外分光光度计：

UV spectrophotometer:

Mettler UV5Bio

恒温恒湿箱：

Constant temperature and humidity chamber:

Memmert HPP110eco

Technology
Technology

技术平台

原料药工艺研发平台：

API Process R&D Platform:

负责原料药或中间体的研究开发工作，包括负责原料药的小试工艺开发、工艺优化、中试放大等研究，制定合理的过程控制、杂质控制策略、最终实现产品工艺稳定且质量有保证的商业化生产。

不对称合成研发平台：

Asymmetric synthesis R&D platform:

通过不对称催化反应、酶催化合成、手性拆分等手段，解决原料药及医药中间体工艺开发过程中的难题，实现绿色高效合成，推动相关产品的商业化。

结晶技术研发平台：

Crystallization technology R&D platform:

通过结晶工艺的开发及优化，确保产品的晶型、晶习和粒度分布，为产品的稳定生产及商业化奠定基础。通过单晶培养与药物分子结构确证，确定药物分子的立体化学结构。

Responsible for the research and development of APIs or intermediates, including responsible for the small-scale process development, process optimization, pilot scale-up and other research of APIs, formulate reasonable process control, impurity control strategies, and finally realize commercial production with stable product process and quality assurance.

Through asymmetric catalytic reaction, enzyme-catalytic synthesis, chiral splitting and other means, solve the problems in the process development of APIs and pharmaceutical intermediates, achieve green and efficient synthesis, and promote the commercialization of related products.

Through the development and optimization of crystallization process, the crystal form, crystal habit and particle size distribution of the product are ensured, laying the foundation for the stable production and commercialization of the product. The stereochemical structure of drug molecules was determined by single crystal culture and confirmation of drug molecular structure.

质量研究平台：

Quality Research Platform:

基于QbD理念的全面质量研究：开发分析方法，进行杂质研究，制定合理的杂质限度并建立质量标准。晶型研究及各阶段产品稳定性研究。

Total quality studies based on the QbD concept: development of analytical methods, conduct impurity studies, set reasonable impurity limits and establish quality standards. Crystal form research and product stability research at various stages.

小核酸药物研发平台：

Oligonucleotide drug development platform:

配备了先进的核酸合成仪和纯化设备，可实现mg至g级的非修饰及修饰的寡核苷酸合成。为ASO 、siRNA、aptamer等寡核苷酸药物研发提供定制合成服务。

Equipped with advanced nucleic acid synthesizer and purification equipment, it can realize the synthesis of unmodified and modified oligonucleotides from mg to g level. Provide customized synthesis services for the development of oligonucleotide drugs such as ASO, siRNA, and aptamer.

Business Scope
Business Capabilities

业务范围/业务能力

鲲泰生物专注于特色原料药及医药中间体的研发、生产和销售。在小核酸药物领域，可以提供RNA，DNA，PMO等寡核苷酸产品的个性化定制合成和生产服务。

Kuntai Biotech focuses on the research and development, production and sales of characteristic APIs and pharmaceutical intermediates. In the field of oligonucleotide drugs, we can provide personalized customized synthesis and production services for oligonucleotide products such as RNA, DNA, and PMO.