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Farmabios manufactures and markets active ingredients for pharmaceutical applications and provides custom synthesis services

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Technologies

A wide range of advanced proprietary technologies in accordance with GMP standards and Pharmacopeas specifications.

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Antineoplastics Plant

After many years of activity in the manufacture and manipulation of highly active substances (steroids. cephalosporins and HPS) Farmabios has established a new department entirely dedicated to the production of antineoplastic APIs which is fully operational since the beginning July 2011.
The department is fully computerized and equipped with reactors varying in capacity from 5 to 200 liters.
The drying and packaging operations take place in specifically designed isolation units utilizing state-of-the-art technologies.

The entire manufacturing process takes place in a closed cycle, starting with the manipulation of the raw materials entering the department and all the way through to the drying and packaging of the products, be they intermediates or finished products.
Containment is guaranteed by means of isolation units located at both the inlets and outlets.
Therefore the plant is ideal for processing highly active antineoplastic that fall into exposure Class 4 according to the Occupational Exposure Band classification.

Overall, the plant is able to offer:

  • A total development process flow (Lab, Kilolab, Pilot, Production)
  • cGMP manufacturing
  • Batch size up to 5 kg making it ideal for process feasibility studies, rapid preparation of samples, perfection of multistep organic synthesis and the commercial production of generic APIs as well as APIs produced for Custom / Contract Manufacturing.


Plant details

  • Automated unit for the production of HIGHLY ACTIVE SUBSTANCES


Equipment

  • GL and S/S reactors with capacity ranging from 5 to 200 litres, hastelloy-C reactors, operating temperature range: -90 °C to 200 °C


Solid–liquid separation

  • Filters within a glove box, in a Class D room
  • Static dryer within a glove box


Special equipment

  • Glove boxes for operating in OEB 4 containment conditions


Area classification

  • Process area - Class D
  • Finishing glove box - Class C


Storage areas for raw materials, intermediates and finished products will be located inside the new plant.
Dedicated in-house QC and R&D laboratories.