​Development and production of drug substances

Development and production of drug substances

Company "PharmTechnjlogy" offers a full range of services concerning development and production of drug substances.

Thanks to flexible module arrangement of product areas we support the partners at different development stages of both innovative drugs and biosimilars.

The following kinds of developments are possible:

 productionofdrugsubstances:

- drug substances obtained by the method of biotechnological synthesis;

- drug substances obtained by the method of separation from the sources of biological and animal origin.

 productionofsterileproducts:

- sterile products manufacturing in aseptic conditions:

ions- spray-dried products, films, powders, solutions for infusions, solutions for entries, suspensions, tablets, emulsions.

Experimental production provides a full cycle of production of genetically engineered pharmaceutical preparations, as well as preparations obtained by chemical-enzymatic synthesis and extracted from natural raw materials. The experimental biotechnological production includes subdivisions that carry out all the stages of the technological process from the cultivation of the cells of the producer and the purification of active pharmaceutical ingredients (API) to the bottling and packaging of finished dosage form (FDF). The organization of control and quality assurance on the PBP (pilot biotechnological production) is carried out by an independent structural unit - the quality control department.

Pilot biotechnological production carries out all stages of farming, namely:

development of high-yield producer strains based on prokaryotic expression systems and eukaryotic cell lines by methods of gen engineering

upstream development of microorganisms, cells of higher plants and mammals

development, scaling and validation of the technological process of obtaining a substance and finished dosage forms, including plant origin

development of the composition and technology of production of liquid and lyophilized finished dosage forms

development and validation of analytical methods for quality control of substances and finished dosage forms, study of their storage stability

full spectrum of preclinical studies based on the laboratory of biological tests

development of production documentation (including pilot industrial, industrial regulations, standard operating procedures, etc.) in accordance with GMP standards (Order of the Ministry of Industry and Trade of the Russian Federation No. 916 dated June 14, 2013) and the GOST R ISO 9000 family of standards.

Also, PharmTehnologis supplies almost any kind of substances, sorbents, serums and other components necessary for production.

For availability and supply capacity of specific items, please contact the company's employees or send an e-mail to info@pharmaspb.com