The GMP Pilot Plant covers over 200 m2 of state-of-the-art cleanroom area, with dedicated HVAC system allowing a full control of environmental conditions (incl. air humidity at the level of 15-60%, both in humidification and dehumidification).

A modern process equipment installed in the area allows to manufacture of:

  • non-sterile solid dosage forms (powders, granulates, coated pellets, tablets, coated tablets; both IR and MR forms, where applicable) in Wet Granulation and Direct Compression technologies. The available batch size (single batch) is up to:
    • 8 kgs of powders / blends
    • 1.5 kgs of granulates
    • uncoated tablets: 8 kgs (in DC) or 1.5 kgs (in WG)
    • 1.2 kgs of coated tablets
  • non-sterile liquid dosage forms (solutions, liquid dispersions) in a batch size up to 5L

The area is GMP-licensed for manufacturing of clinical-use drug products, including investigational drug products. That allows the company to offer:

  • manufacturing of clinical-use drug products, both as a part of contract development or contract manufacturing of drug product
  • contract manufacturing of low-volume market drug products (in bulk)