In 2011, PHARMAPARK set up the Research and Development Department.
The Department carries out full-cycle development of biopharmaceuticals (both APIs and medicinal forms) based on recombinant proteins, including chemically modified ones. The scope of development includes all stages:
- creating highly productive and stable strains based on prokaryotic (E. coli) and eukaryotic (yeasts, CHO-K1, CHO-S, CHO-DG44) cell lines using state-of-the-art biotechnological approaches
- API production process development, scale-up and validation
- development and validation of analytical methods for quality control of APIs and medicinal forms
- formulation and process development for production of liquid and freeze-dried dosage forms, stability studies
- drafting CTD for regulatory filing.
The department has a proven track record of developing a wide range of biopharmaceuticals, including those based on monoclonal antibodies, cytokines, glycosylated proteins, etc.
Pharmaceutical development is comprehensively documented according to the requirements of ISO 9001:2015, other Russian, and international regulatory documents including ICHQ8, ICHQ10, and ICHQ11.
The R&D Department includes the following units:
- Project Management Department
- Prokaryotes Cultivation Laboratory
- Cell Engineering Department
- Biochemistry Laboratory
- Medicinal Forms Development Group
- Analytical Methods Development and Transfer Department
- Process Scale-up and Validation Department.
The R&D facility has the area of 1000 square meters, including 100 square meters class D space and 600 square meters controlled space.
The R&D Department has state-of-the-art equipment including a variety of bioreactors enabling the optimal equipment selection for each process under development.
PHARMAPARK has joint pharmaceutical development projects with a number of Russian and foreign companies and institutions. Thus, the R&D Department has a long history of successful cooperation with the State Institute for Genetics and Selection of Industrial Microorganisms. Our foreign partners include companies and research centers in Switzerland, the USA, Canada, and Germany.