Pharmaceutical complex for production of finished dosage forms in Yaroslavl.
Address: 150000, Yaroslavl, ulitsa Gromova, 15
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.
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.
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
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.