Pharmaceutical complex in Yaroslavl

Pharmaceutical complex for production of finished dosage forms in Yaroslavl.

Address: 150000, Yaroslavl, ulitsa Gromova, 15

Product Portfolio:

The portfolio of the company is represented by various groups of medicinal preparations for the following areas of application: oncology, hematology, cardiology, immune diseases, anti microbial preparations, antivirals (including HCV, HIV therapy), medicines used in transplantology, multiple sclerosis, hemophilia and diabetes as well as muscle relaxants, radiopaque contrast agents and preparations for anaesthesia.

Project execution

Such services as consulting, development, design and validation were provided by NNE PharmaPlan. It is a world leading engineering company in the sphere of pharm industry and biotechnologies.

The facility fully meets EMA (European Medical Agency) standards, FDA (Food and Drug Administration, USA) standards and in many parameters it surpasses GMA standards. Since the launch of the plant there were successfully carried out audits by the world leading drug manufacturers like Abbvie , Amgen, Astellas, AstraZeneca, BMS, Boryung, Dr.Reddy’s, Eli Lilly, Ferring, Glaxo Smith Kline, Johnson& Johnson, Mallinckrodt, MSD, Pfizer, Roche, Sanofi and others.

AO “R-Pharm” applies isolating and hurdle technologies in all production areas and that provides a complex system of protection of the personnel and environment protection. Engineering design provides for all the technical solutions allowing to save energy resources when the building is in service and during manufacturing processes.

Innovative production of Biopharmaceuticals based on GE Healthcare technology

September 20th, 2016 – A ceremonial opening of a new line for production of medicinal proteins took place at R-Pharm finished dosage form production facility in Yaroslavl. 

The platform based on application of innovative, so-called, single-use technologies allows producing considerable amounts of MAbs (monoclonal bodies) and other biotechnological products. As opposed to the standard solutions, single-use technologies help to considerably save costs and time. At every stage of production (cultivation, purification, chromatography) single-use components are applied. They are utilized immediately after their use and are replaced by new ones and this helps to avoid labor consuming and expensive purification process. Application of single-use technologies provides flexibility in modification of production processes and a prompt rebuild of a line for production of new products if required. A unified automation system allows to control the whole workflow and adjust single processes. That helps to simplify equipment installation and assembly and its implementation on site. Besides, single-use technologies allow to exclude contamination of produced products and to reduce costs for purification of the processing line after production of a new batch of products.

Launch of a new line of biopharmaceuticals is an important step to batch production of biopharmaceuticals including innovative products and biosimilars with high export potential. The production line is validated according to GMP requirements.