工艺开发和工艺优化

 

耐士的工艺研发技术团队可提供路线研发、中试、优化到放大生产的全过程服务。特别致力于技术壁垒高、难度大、附加值高的有机中间体、特殊氨基酸、医药原料药和多肽类化合物的工艺开发、优化及杂质定性等研究。公司也同时提供技术转让服务,可以给客户提供详尽的工艺技术路线、参数,帮助客户设备选购和搭建,现场指导客户实际掌握全套工艺生产。

 

 

Our highly experienced process development team can provide process design, process development and/or process optimization services with expertise in specialty chemical intermediates、amino acids、drug API、peptides products and related impurity synthesis/characterization. We help clients develop robust and efficient process for scale up needs. We offer full tech transfer service, providing detailed process report with all critical process parameters, guiding in instrument selection and setup, and on-site consulting and advising till client’s fully comprehension of the process.  

 

API 原料的开发与生产

为了方便您药物的研发和生产,我们提供独家API原料的工艺开发和定制合成服务,确保对您产品市场化后对API原料大量需求的持续供应。

定制合成

我们的合成化学家们的日常工作就是为客户合成参考化合物,中间体,候选产品,其规模可从毫克到几十公斤(GLP级别)。我们的团队精通新路线设计和路线优化,已成功完成数个高难度化合物开发及工艺技术优化的工作。

同时我们给您提供高附加值的化合物:

 

API有机活性中间体

特种氨基酸

我们的生产与工艺团队不仅擅长于优化现有路线,更擅长药物中间体的放大生产。

耐士的技术团队可以为您提供路线研发、中试、优化到放大生产的全过程服务。

 同时我们特别致力于技术壁垒高、难度大、附加值高的有机中间体、特殊氨基酸、医药原料药和多肽类药物化合物的工艺开发、优化及杂质定性等研究。

耐士生物技术提供的各种工艺开发服务包括:

1.       化合物规模生产的工艺开发

2.       新合成路线的开发,并用于规模化生产

3.       生产工艺优化,降低成本和提高效率

4.       小试,中试工艺路线的摸索和放大生产

5.       关键工艺参数评估

6.       工艺技术转让

Development and Production of API raw materials

In order to facilitate the development and production of your drugs, we offer exclusive API raw materials and custom synthesis process development services to ensure continuous supply of your product after marketization.

Custom Synthesis

Our synthetic chemists’ daily work is to synthesis reference compounds, intermediates, candidate product for customers, its scale varies from mg to kg level (GLP). Our team is proficient in the design and optimization of new route. We have completed several difficult compounds development and technology optimization.

Meanwhile we can provide you with high value-added compounds:

API Organic Reactive Intermediates

Special Amino Acid


 

Our production and technology team  is not only good at optimizing existing routes, more adept at amplifying the production of pharmaceutical intermediates.

Our process R & D team can provide the entire process including route development, pilot production, optimization and large scale production.At the same tiome, we are committed to process development, optimization and characterization of impurities of organic intermediates, special amino acids, peptide pharmaceutical raw materials and pharmaceutical compounds with difficult technical barriers and high value-added.


 

Rysstech offers a variety of process development services, including:

1.       Pocess development of compound`s mass production

2.       Development of new synthetic routes, and used for large-scale production

3.       Production process optimization, reduce costs and improve efficiency

4.       Exploration and  amplification production of laboratory scale and pilot scale tests

5.       Assessment of the key process parameters

6.       Transfer of the process technology

 

 

纯化工艺开发

  得以整套的国外品牌设备---Biotage中低压制备到novasep高压液相制备的技术和设备工艺支持配合经验丰富的研发团队,耐士致力于医药 纯化工艺开发服务。我们承诺开发的工艺具有可重显性,可放大性,及商业化可验证性。独家的DAC轴向压缩以及多柱连续色谱技术,可以帮助我们的客户解决壁 垒高、难度大的纯化工艺问题。

      我们的工艺研发技术团队可以为您提供路线研发、中试、优化到放大生产的全过程服务。

 

大规模纯化

   手性和非手性的纯化

   SFC,HPLC,MPLC,Varicol和SMB平台

   每天分离数千克化合物的能力

手性分离

   手性分离方法的开发

   毫克级的手性分离

   大量的(数千克)手性分离

   手性化合物e.e 值的测定

   纯化的对映体的消旋化研究

制备色谱

   高压制备液相色谱系统HPLC

   多柱循环色谱(Varicol和SMB)

   中压和低压制备色谱(LPLC, MPLC)

先进纯化技术

   结晶和多状态控制,蒸馏,膜过滤(纳滤,超滤,微滤),喷雾干燥

Rysstech, equipped with complete set of foreign brand instrument (Biotage Flash Chromatography, Novasep HPLC etc.) and experienced R & D team, is committed to the purification process development services in the pharmaceutical industry. We guarantee that the development processes are reproduceable, scalable, and  verifiable of commercialization. The exclusive DAC axial compression and multi-column continuous chromatography technology can help our customers solve high-barrier, difficult purification process issues.

Our process R & D team can provide the entire process including route development, pilot production, optimization and large scale production.

Large-scale purification

          Purification of chiral and non-chiral

          FC, HPLC, MPLC, Varicol and SMB platform

          The ability to separate kilograms of materials per day

Chiral Separation

          Development of Chiral Separation Methods

          Milligram chiral separation

          A large number of(several kilograms) Chiral Separation

          Chiral compounds e.e. values

          Research of the purified racemic enantiomer

Preparative chromatography

          High Performance Liquid Chromatography (HPLC)

          Industrial Supercritical Fluid Chromatography Systems

          Multi-columns circulation chromatography(Varicol and SMB)

          Medium and low pressure preparative liquid chromatography

Advanced Purification Technology

          Crystalline and multi-state control, distillation, membrane filtration (nanofiltration, ultrafiltration, microfiltration), spray drying