Researcher’s background and expertise
LUPI’s PHD chemists have a strong background on the optimisation and the industrialisation, scale-up and robustness evaluation of chemical processes, as well as identification of innovative and non-infringing synthetic routes. Within the R&D group, a selected team of analytical researchers is dedicated to Process Analytical Technology (PAT), Design of Experiments (DOE), process calorimetry, safety evaluation, impurity profile investigation and characterisation and solid state chemistry of final Active Pharmaceuticals Ingredients, including polymorphic form evaluation.
Researching with a Green Chemistry approach
The general Green Chemistry approach and related metrics are thoroughly used in the process development phase, with a quantitative comparison of each process step before and after its optimization. Green Chemistry aims at minimising or eliminating the use of nonrenewable resources and the generation of hazardous substances to have a sustainable impact on the environment.
LUPI’s laboratory and equipments
In addition to standard equipment for process research, a current Good Manufacturing Practices (cGMP) kilo lab is available, equipped with glass reactors and clean rooms designed to operate at ISO 7 and 5. LUPI has also a fully cGMP pilot plant with a total capacity of 1450 liters and two separated suites, operating at ISO 7 and ISO 8, guaranteeing high level of confinement.