Analytical Development & Quality Control

Our analytical development and quality control facilities are equipped to support the development and manufacturing of your products.

  • HPLC (UV, DAD, ELSD, RI)
  • GC (FID, headspace)
  • UV/VIS
  • Karl Fischer
  • Infrared Spectroscopy (FT-IR)
  • In-vitro dissolution testing (USP 1 & 2)
  • Particle size (Dynamic Light Scattering & Laser Diffraction)
  • Differential Scanning Calorimetry (DSC)
  • Handling of high potency drugs

Other characterization techniques are available through our long-term partnership with expert contract service companies : XRPD, surface area, LC/MS, microbiology testing, ICH stability studies…

Product Development

Our facilities include a wide range of supercritical fluid processing units to develop your product from laboratory scale feasibility trials to pilot non-GMP batches.

Small scale units are operated in dedicated development laboratories, some of them being suitable for the processing of highly potent compounds. These flexible units are designed to work with minimal API amount and make it possible to meet very short deadlines.

Pilot scale units are operated in one of our clean rooms dedicated to the development and manufacturing of preclinical materials.

All non-GMP development equipments are calibrated following a validation plan controlled by our Quality Unit and are designed and operated to prevent cross-contamination.

GMP Manufacturing

Manufacturing of clinical batches is performed in a ISO Class 7 clean room which includes ISO Class 5 areas for critical downstream and upstream operations.
 
The GMP manufacturing area is designed for the operation of particle design and purification processes pertaining to our supercritical fluid technology platform.
On a project basis, other manufacturing techniques are available to provide our customers with products which require complementary processing steps: mixing, milling, vaccum drying, freeze-drying…
 
Manufacturing of clinical trial material is carried out in compliance with GMP Part II “Active Substances as Starting Materials”.

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