Capabilities

Ardena provides drug product services through dedicated analytical, formulation development, manufacturing and scientific reporting teams. Oversight for each project is provided by a dedicated, multidisciplinary management team.

Our fully equipped drug product development facility houses separate analytical and formulation development laboratories as well as GMP accredited manufacturing suites. Our quality GMP manufacturing suites have sophisticated systems that ensure the drug products that are manufactured meet the highest quality standards. The site also has a state-of-the-art warehousing facility and separate packaging and labelling areas.

In addition, the Ardena drug product services facility also has several >100m2 walk-in stability testing rooms, all of which are operated in accordance with ICH recommendations and have continuous monitoring systems capable of monitoring samples in real time, 24/7.

Ardena’s formulation characterisation and analytical services are comprehensive allowing us to provide customers with the most detailed data available. Our drug product testing technologies include:

  • HPLC/UPLC-(H) technology with detector systems (RI, PDA,MS) that run Empower software
  • A suite of state of the art dissolution testing technologies USP-1/USP-2 and USP-4 (Sotax, VanKell, Distek)
  • Equipment for testing including UV-VIS spectroscopy, pH, osmolality, Karl Fisher titration, IR spectroscopy, GC, particle counting (HIAC), UV-stress testing and micro plate optical density reader.
  • A Brookfield LVDVII+Pro viscosity meter
  • Swift – Optical microscope M10LB-S
  • Mettler-Toledo Differential scanning calorimeter DSC1
  • Density meter Anton Paar: DMA 35N
  • Friability testing, tablet hardness , tapped density (Copley), powder flow analysis (Pharmatech)
  • Particle size in dry and liquid state (Sympatec Helios and Malvern Mastersizer).

Ardena’s GMP production suites house cutting-edge technology that ensures drug products are produced in accordance with specifications, consistently and efficiently. Our range of technologies include:

  • Powder blenders of various sizes (up to 25 L)
  • Powder pipette, sieving equipment
  • Manual and fully automated systems for capsule production, counting and weight checking
  • Technologies for tabletting, including production of minitablets and tablet coating
  • Wet milling technologies for nanosuspension production
  • High-shear liquid mixing
  • Tube filling and tube sealing equipment
  • Spray drying
  • Fluid bed granulation
  • Wurster coating
  • Dedicated weigh booth
  • Class 2 Biohazard Safety Cabinet
  • Primary packaging into a wide range types vials, bottles, sachets and tubes