Mabscale

Mabscale is a full-cycle company providing production of both drug substance and finished dosage forms. The company has created its own expression system for producing clones, transferring laboratory technologies to industrial production.

History

2025: Completion of installation of industrial equipment on the production line of active pharmaceutical substances

The full-cycle biotechnology company Mabscale, part of Ozone Pharmaceuticals the Group, has completed the installation of industrial equipment on the active pharmaceutical substances production line (API). This was announced Ozone Pharmaceuticals by "" on March 5, 2025. In the production complex located in, Togliatti Special Economic Zone three bioreactors of 2000 liters were installed, industrial chromatographs and the necessary capacitive and auxiliary equipment. Industrial lines will allow Mabscale to produce up to 1 million vials of lyophilisates, 5 million pre-filled syringes and more than 4 million vials of sterile solutions annually. The total investment in installed equipment amounted to 0.8 billion. rubles The company plans to start selling the first biotechnological drugs in 2027.

During 2024, Mabscale carried out a complete reconstruction of the finished dosage form site. Vial filling lines, syringe machine and freeze drying were put into operation (lyophilization of proteins is an important element of production, aimed at maintaining their integrity after storage).

The next stage after the installation of the equipment is completed will be the acceptance tests at the pharmaceutical substances production site. The tests will make sure that the equipment works in full compliance with the technical requirements and safety standards. The production of biological APIs requires the use of advanced technological solutions and appropriate equipment, since living organisms that need optimal conditions are used to produce antibodies. This applies to both fermentation in bioreactors and subsequent production steps.

The completion of the acceptance testing process will allow the full formation of the Mabscale production loop and the release of drugs from the company's portfolio on the market in an industrial volume.

Шаблон:Quote 'author=said Alexander Petrov, Ph.D., Deputy General Director of Mabscale for Development. health care

As of March 2025, at various stages of development and registration, the company has more than 25 biosimilar drugs (biosimilars) based on monoclonal antibodies and other recombinant proteins. The selected drugs represent the most advanced biopharmaceutical solutions and are designed to ensure that effective treatments are available to a wide range of patients.