CDMO Business - Kohn & Shawn Pharmatech

CDMO Business

It plays an important role in the research and development stage of innovative drugs, and can serve customers to complete various basic research work and establish research databases. We strictly control the quality and schedule to provide domestic and foreign customers with intermediates required for new drug synthesis, which can achieve production from milligram level to tonnage level.

Core Competence

Have a good understanding of the whole process of new drug development and production

To provide pharmaceutical customers with innovative drug production process research and development, optimization, formulation development and trial production services, and on the basis of the above research and development, development and other services to further provide customized production services from kg to ton.

R&d and production capacity

Invest in the development of new technologies and improved production processes, with relevant skills and experience. Deep cultivation in the field of pyrazine for 10 years, independent research and development to form a pyrazine compound library containing 3000+ pyrazine products, the current products are sold to the United States, Japan, South Korea, the United Kingdom and other 11 countries. Based on the precise control of chiral drug technology platform, intrinsically safe green process technology platform, the R & D engineer team will be a series of difficult synthesis, purification and other specific technologies for scientific combination and flexible application, so as to achieve a variety of complex and difficult drug independent research and development production process.

Rich knowledge reserve in innovative drug development and production

On the basis of comprehensive consideration of the feasibility of the process route, whether the production can be scaled up, and whether the product quality meets the requirements, a stable and reliable production process is designed by using easier access to starting raw materials, a process path with higher yield, a shorter synthesis step, and fewer high-risk reactions and dangerous substances, so as to minimize production costs and improve production efficiency. Achieve green environmental protection and safety in the production process.

A deep understanding of all aspects of new drug development and production can be widely used

It can deeply integrate its own high-tech value-added process research and development capabilities with large-scale production capabilities, and through the supply mode of clinical trial production and commercial production, it can deeply connect the entire supply chain system of pharmaceutical enterprise customers from research and development, procurement to production, helping pharmaceutical enterprises to improve the efficiency of new drug research and development and reduce the cost of drug research and development and production.

Service Content

In terms of service content, in a progressive way, it closely fits the early research and development needs of pharmaceutical enterprise customers, helping customers to achieve step by step amplification from kg to ton level, and finally achieve large-scale production of products.

Preclinical research pilot stage

Mainly carry out molecular formula verification, process route exploration and research and development, and complete the stability experiment and kilogram verification of products

In the pilot phase

Mainly carry out step by step amplification test, and adjust and optimize the process according to the actual situation and related problems in the process of amplification production

In the production and process validation phase

Determine the process parameters suitable for commercial production equipment, and form relatively perfect process procedures. On the basis of all the above research and development and production work, finally realize the commercial mass production and sales of the product.

Development Advantage

It can provide process research and development, optimization and commercial production services for pharmaceutical enterprises at the same time in the research and development and commercialization stage, so as to provide one-stop service for the entire new drug research and development and production.

In the drug discovery and preclinical research and development stage, have the ability to participate in customer research and development projects, using new technologies with independent intellectual property rights or through the innovation of traditional processes, to provide process design, API process research and production, drug effectiveness and stability testing, small-scale test sample production and other services. Greatly improve production efficiency or reduce production costs to help customers accelerate the launch of products in research.

In the commercialization stage, we can provide services such as formulation process development and optimization, cGMP quality assurance, API and large-scale production of preparations. In particular, the ability to provide process design and small-scale production services such as apis for the early research and development stage gives us a significant advantage in the competition for orders in the commercialization stage.