Master in Medicinal and Biopharmaceutical Chemistry

Process Development of Active Pharmaceutical Ingredients (APIs)



Learning outcomes

The main objective of this Curricular Unit is to provide to the students the competencies and knowledge about the concepts, methodologies and technologies utilized in the development of chemical processes intended to be manufactured at industrial scale. Classes will cover themes such as route scouting, scalable reactions, metrics and sustainability, process hazard and safety, quality by design (QbD), analytical characterization, process controls and current regulatory framework. The concepts acquired in the course will be relevant not only in the scope of their academic curriculum, but also in their professional future.


  1. Regulatory aspects and life cycle of active pharmaceutical ingredients

Current regulatory framework of the submission of manufacturing processes of active pharmaceutical ingredients. Good Manufacturing Practices (GMP). Life cycle of the manufacturing processes of APIs – from Phase I to Commercial.

  1. From bench to plant

Process safety. Scale effects. First scale-up in a process laboratory. Route scouting based on sustainability metrics and costs. Risk assessments. Process mapping (impurities, mass balance and waste).

  1. Process development

Unit operations (reaction, work-up and isolation). Approaches to optimization (one-factor-at-a-time, statistical and mechanistic modelling). Equipment and technologies. Analytical chemistry and stability of drug substances.

  1. Controls and filling

Normal Operating Ranges and Process Acceptable Ranges (NOR/PAR). Process Design space. Process controls and specifications.