R&D CENTER
Own R&D Center develops original, generic and hybrid drugs based on small molecules of chemical origin.
We have created a state-of-the-art research and manufacturing platform for the development and manufacture of our own active pharmaceutical ingredients and finished pharmaceutical products based on them.
more than4 000m2
is occupied by the OncoTarget
research and production complex
API DEVELOPMENT:
development of synthesis methods and technology to manufacture APIs;
standardization of API quality indicators according to the requirements of the Eurasian Economic Union and ICH;
development of synthesis methods and technology to manufacture APIs;
development of synthesis methods and technology to manufacture finished products;
study of the stability and degradation resistance of APIs;
development of synthesis methods and technology to manufacture APIs;
standardization of API quality indicators according to the requirements of the Eurasian Economic Union and ICH;
development of synthesis methods and technology to manufacture APIs;
development of synthesis methods and technology to manufacture finished products;
study of the stability and degradation resistance of APIs;
FROM INITIATING DEVELOPMENT OF SUBSTANCES TO LAUNCHING THE MANUFACTURING CYCLE
01
Initiating substance
development
02
- Literary collection and theoretical study of methods of synthesis and analysis
- Patent search
- Generating patent reports
- Reagent ordering, logistics and maintenance support
03
- Laboratory study of synthesis methods
- Selection an optimal synthesis path based on analysis of technological and environmental parameters
- Development of methods to analyze semi-finished products and substances
- Validation of analytical methods
- Preparation of regulatory documentation
- Creation of section 3.2.S (for registration)
- Preparation and filing of patent applications in the event know-how is created in the research process
04
- Creation of manufacturing documentation
- Manufacturing validation
- Scaling substances manufacturing
05
Launching the manufacturing cycle
DEVELOPMENT OF FINISHED PRODUCTS:
pharmaceutical drug development;
search for technological solutions, scaling and transfer of technology to the manufacturing site;
standardization of medicine quality indicators in accordance with Eurasian Economic Union and ICH requirements;
development, validation, verification and transfer of analytical methods;
research on drug stability.
pharmaceutical drug development;
search for technological solutions, scaling and transfer of technology to the manufacturing site;
standardization of medicine quality indicators in accordance with Eurasian Economic Union and ICH requirements;
development, validation, verification and transfer of analytical methods;
research on drug stability.
HOW WE DEVELOP DRUGS:
1
Target selection
2
Development of API formulation and quality control methods
3
Development of finished product formulation and quality control methods
4
Scaling and transfer
5
Preclinical and clinical studies
6
Preparation for drug registration
7
Drug registration
Manufacturing