API expertise

API expertise

Angelini’s strength in API Research & Development is proven by being the partner of choice for large pharma and smaller biotech companies seeking integrated drug development solutions to accelerate R&D pipelines from bench to market.

With cutting-edge R&D labs and continuous investment in novel chemical technologies, Angelini remains at the forefront of scientific and industrial know-how in the development and manufacturing of small molecule APIs for custom business.

With over 800 m2 of lab spaces dedicated to non cGMP chemical and analytical development and 230 m2 lab space dedicated to optimization, transfer and scale up, Angelini count 30 people in R&D and Optimization groups with PhD or degree in chemistry and pharmaceutical chemistry.

Angelini Fine Chemicals industrial experience in process chemistry and scale-up is recognized in the global pharmaceutical outsourcing market, which makes Angelini an attractive and trusted CDMO partner. Qualified R&D team is responsible for chemical and analytical development for its Customers, by designing and developing of innovative, robust and scalable synthetic route for industrial manufacturing of small molecules.

Angelini R&D services include:

  • Evaluation, scouting and development of new synthetic routes for RSMs and APIs
  • Process development up to industrial scale
  • Process intensification
  • Development and optimization of analytical methods
  • Development of robust and scalable crystallization procedures
  • Study of physical properties (Particle Size Distribution, X-ray Diffractometry, Optical Microscopy)
  • Study of micronization
  • Genotoxic evaluation
  • Risk and process parameters assessment
  • Technology transfer of new process into industrial units
  • Clinical and commercial supply