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In recent years, the competition in the global pharmaceutical industry has become increasingly fierce, the division of labor in the pharmaceutical industry chain has become increasingly refined, and specialized outsourcing in the pharmaceutical industry has become an important strategic choice for pharmaceutical companies
.
With the continuous improvement of the degree of specialization of pharmaceutical outsourcing service institutions, the content of pharmaceutical outsourcing services gradually covers all links from disease target research, drug compound screening, clinical trial services, process research and development, large-scale production to market sales
.
According to the content of the services provided, pharmaceutical outsourcing service agencies mainly include CRO, CMO, CDMO enterprises,
etc.
PART.
0 1
0 1
CROs, CMOs, CDMOs
CROs, CMOs, CDMOs CRO enterprises (contract custom research and development institutions) refer to institutions that provide professional services to pharmaceutical companies and research and development institutions in the process of drug research and development through contracts
.
CRO companies serve the entire stage of drug development and are responsible for all or part of the activities involved in the drug development process.
The main services provided by CRO enterprises (contract custom R&D institutions)
Unlike CRO companies, CMO/CDMO companies mainly focus on the production services of drugs
.
Among them, CMO (custom contract manufacturing organization) refers to an enterprise that provides pharmaceutical companies with services such as the production and packaging of intermediates, APIs, and preparations in the form of contract customization
CMO/CDMO companies mainly focus on drug production services.
CDMO Enterprise (Contract Custom R&D and Production Organization)
PART.
0 2
0 2
Differences between the three in drug design and development
Differences between the three in drug design and development
PART.
0 3
0 3
Comparison of CDMO Enterprises in Design and R&D Fields
Comparison of CDMO Enterprises in Design and R&D Fields
PART.
0 4
0 4
R&D process of CDMO business
R&D process of CDMO business
PART.
0 5
0 5
The relationship between CDMO services and products sold
The relationship between CDMO services and products sold The sale of goods is the final delivery form of the company's CDMO service results
.
Drug R&D is a systematic project with high risk, high investment and long cycle
First, CDMO service is the business process of final commodity formation
.
.
The main goal of the CDMO service provided by the company to customers is to successfully develop pharmaceutical intermediates or APIs and other products that are feasible for commercial production according to customer requirements
.
CDMO service is the process by which the final product is formed
Second, CDMO service is a necessary condition to meet the customized needs of customers
.
.
Unlike most general products, which can be organized and implemented after receiving orders, customized pharmaceutical products are special products with a strong degree of professionalism and customization
.
In the process of customized R&D and customized production, the company must always know the specific needs of customized customers, and determine the technical details of the product through repeated technical exchanges
In order to meet the customized needs of different customers at different stages of the drug life cycle, the company needs to provide personalized customized R&D and production services
.
According to the requirements of customized customers, based on the deep understanding of process technology, the company develops and determines suitable synthesis paths and conditions, and through targeted adjustment of key process parameters, achieves precise control of key properties of target compounds to meet customer requirements.
Therefore, the customized products that pharmaceutical enterprise customers expect to obtain through entrusted cooperation can only be realized through the detailed service process of CDMO, which is a necessary condition for the formation of customized products
.
Third, end customers participate in the CDMO services provided by the company through cooperative procedures such as quality audits
.
.
Due to the particularity of the pharmaceutical industry, the customized R&D production in the pharmaceutical industry is quite different from the general contract entrustment
.
The end customer entrusts the company to customize the drug development and production process, and pays great attention to the safety, effectiveness and quality of the drug and its intermediates.
It is impossible to make a comprehensive and effective judgment on the drug production process only based on the final delivered goods
.
Therefore, in the daily CDMO cooperation, pharmaceutical enterprise customers often participate in the company's CDMO service process through the qualification of qualified suppliers, regular or irregular quality audits, etc.
, and implement the safety, effectiveness and quality controllable requirements of drug registration.
to the whole process of custom R&D and production
.
Therefore, the CDMO service process is a key way for pharmaceutical enterprise customers to ensure that the final delivery of pharmaceutical intermediates or API products meets their quality requirements in all aspects
.
Fourth, the company's CDMO service content and achievement delivery form are basically consistent with the CDMO service content and achievement delivery form of comparable listed companies in the same industry
.
.
The specific comparison is as follows:
To sum up, the sale of goods is the final delivery form of the company's CDMO service results, and CDMO services are the business process in which the final goods are formed
.
The CDMO service process is the only way to form the final product , which is mainly reflected in the following two aspects:
On the one hand, the products delivered by the company to customers are all customized products, and the customized R&D and production needs of pharmaceutical companies can only be met through the detailed service process of CDMO;
On the other hand, the CDMO service process is a key way for pharmaceutical company customers to ensure that the company's final delivery of pharmaceutical intermediates or API products meets their drug requirements in all aspects
.
In addition, the company's CDMO service process and results delivery form are basically consistent with the same industry, in line with industry practices
.