In Organistry we work at all stages of developing a process for the manufacture of an active ingredient. We review the literature to study the patent situation of an API and if its manufacture is viable we go ahead with experimental work that includes:

Process Development
  • Study of new preparations.
  • Evaluation of different synthetic routes and choice according to yield, API impurity profile, cost and availability of raw materials, simplicity and environmental impact.
  • Detailed study of reaction parameters, the connection between steps, the crystallization of the final product or its resolution and parameters that affect to polymorphism.
  • Identification of critical parameters and setting their range of security through experiments under conditions of stress.
  • Analytical support from the start of the project.
  • Scaling and validation process in reactor (1-10 L).
  • Preparation of standards of related impurities.

Communication with our customers is very close. We hold regular meetings and provide reports and compilations of our experimental work, allowing us to make important decisions together, taking into account the client's vision and way of working at the plant.

At the end of the project, a report on technology transfer is submitted and it includes process operations, critical parameters, reaction controls, analytical methods developed, and so on. Technology transfer can also be done by reproducing the process in front of the customer on the same scale as the validation batches and delivering all necessary documentation.