Production

Full-cycle production of new generation drugs.

About the Division

Production Mabscale, LLC has modern equipment for industrial production of full-cycle biotechnological preparations: from the cultivation of producer strains to manufacturing finished dosage forms. Our production staff undergoes timely training and advanced training under national and international GMP quality standards. The growth of employees’ skills is one of the main principles of the Company’s HR policy.

The Company’s priority is the Production of high-quality and safe drugs under the GMP international quality standards.

About
> 0 mln
Vials per year
of liquid forms
> 0 mln
Vials per year
of lyophilized forms
> 0 mln
Syringes per year
Pre-filled syringes

Engineering systems

Engineering systems ensure uninterrupted supply of the production with clean media in accordance with the main GEP and ISPE provisions. The cleanroom complex with a total surface area of 1,050 sq.m meets the requirements of ISO 14644-1. 

Our in-house water treatment site is equipped with facilities by Stilmas (Italy); its capacity for water treatment is 2,000 liters per hour; for water for injection, 1,275 liters per hour.

The air treatment site is designed in line with international standards and equipped with facilities by Airmec (Italy).

Receiving, storage, drying, and distribution of compressed air for uninterrupted supply of production is provided by a compressor unit by Atlas Copco (Sweden). 

Receiving, storage and distribution of gaseous nitrogen for uninterrupted supply of production is provided by a station by Atlas Copco (Sweden). 

The main production equipment is connected to power supply of the first special category through an uninterruptible power supply system by Legrand (France).

Production area for Active Pharmaceutical Ingredients (API)

The active pharmaceutical ingredient production area is equipped with modern European facilities involving Single Use systems. The maximum loading of the site allows producing up to 100,000 liters of culture liquid per year.

Production site for finished dosage forms (FDFs)

The production site for finished dosage forms is equipped with modern European facilities for production of sterile medicinal products in vials, syringes, and cartridges. The potential production capacity for finished sterile dosage forms is:

  • 14,1 млн. флаконов в год для жидких форм
  • 4,1 млн. флаконов в год для лиофилизатов
  • 8,7 млн. преднаполненных шприцев в год
  • 2.5 million cartridges per year

Gallery