About us

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Synthetic Biotechnology medium scale manufacturer of antibodies,  recombinant proteins, and critical assay reagents with solid experience. We also provides contract R&D, process development, and manufacturing services to the biopharmaceutical and diagnostic markets.

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• 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

          

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:​

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• 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 800 square meters, including 600 square meters class D space and 200 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.

 Our foreign partners include companies and research centers in China,Switzerland, USA, Canada, and Germany.

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