API

Process Development Activities from Discovery Support to Market.

• Fast definition, development and implementation of robust and safe API Process Technology
  
  
• Supply of APIs and intermediates to support projects from Discovery through Commercialization of NCEs by chemical synthesis
  
  
• Life cycle management of products (process improvements, new polymorphs, second generation route...)

Expertise

• Long experience with the handling of cytotoxics / potent compounds, from the Discovery support to the Technology Transfer to industrial plants.
  
  
• Custom designed Kilo labs and high containment facilities allowing for manipulation of class 5 compounds
  
  
• cGMP facilities
  
  
• Parallel synthesis for fast process development and optimization. Design of Experiments
  
  
• Dedicated lab for process safety / process engineering
  
  
• Synthetic route finding and selection (enabling route / second generation)
  
  
• Integration with Analytical Development to provide fast structural characterization and timely definition of IPCs and specs
  
  
• Support to the CMC group providing data for registrations

Chemical Synthesis

• Laboratories.
  
  7 laboratories of Process Research equipped with HPLC, 400 MHz NMR, automated multireactors.
  
  
  
• Traditional Pilot Plant.§
  
  Products not requiring high containment are prepared in this area. Maximum batch size around 15 kg. Equipment includes Hastelloy criogenic units operating in the range -70 °C / +130 °C, hydrogenator and prep chromatography.
  
  
  
• High containment facility.
  
  The area is divided into 4 independent suites, with dedicated utilities for optimal segregation of different projects. Solids are handled inside glove boxes under inert atmosphere. Nitrogen inlet and outlet treated with absolute filters. GMP preparations separated from development work. All operations may be carried out under DCS control. Gas emissions conveyed to scrubbers and active carbon absorbers. Deactivation in place for all waste streams.

Process Safety Lab

The Process Safety Lab performs activities aimed at ensuring safe scale up, including determination of thermal stability of the intermediates, compatibility with the materials, study of runaway reactions, but also substantially contributes to the engineering of the process.

Equipment includes:

• Adiabatic calorimeter ARC 2000
  
• Differential Scanning Calorimeter Mettler DSC822, TC15
  
• FT-IR Mettler probe
  
• Lasentech probe
  
• Calvet calorimeter Setaram C80 Setaram
  
• Reaction calorimeter RC1 Mettler Toledo
  
• DTA hot stage microscope system Mettler Zeiss FP90
  
• Kuhner apparatus