May 10th, 2021
Enantia has inaugurated a new Kilo Lab for the development, scale up and production of key intermediates and preclinical compounds.
Usually, at the beginning of an investigation, industrially interesting compounds are obtained through non scalable methods. These processes can be carried out in a laboratory setting for small quantities, but require alternative approaches when larger quantities are needed because when the reaction is scaled up key aspects such as its safety, efficiency and impurity profile, change. This is why developing the process in an initial Kilo Lab is key to understand and control these aspects. One of Enantia’s main activities in its Chemical R&D department is precisely the development of safe and industrially scalable synthetic routes, considering also their economic viability as well as its environmental footprint.
Similarly, our Solid State R&D team will also make the most of this new equipment when developing robust, efficient and scalable methods to obtain solid forms for candidates and active pharmaceutical ingredients – like polymorphs, salts, solvates and cocrystals – as well as to use them in purification and resolution methods (you can read an example of purification through cocrystallization here).
The new Kilo lab is placed at Enantia’s Barcelona Science Park site, and it is equipped with a 15 L jacketed reactor and a 20 L auxiliary reactor, both fitted with mechanical stirrers, and allowing temperatures up to 150 °C and reactions under inert atmosphere. This equipment enables studying the scale up from multigram to kilogram scale, being this phase where more development and optimization is needed. Once Enantia has developed the processes in the Kilo Lab, it is possible to execute a quick technology transfer to the client’s pilot plant or alternatively, the client’s contract manufacturing partner of choice.
Additionally, Enantia offers the possibility to prepare batches of preclinical compounds, advanced intermediates and building-blocks within the kilogram scale.
Enantia works following very high-quality standards and is ISO-9001:2015 certified. Besides these services, Enantia collaborates with trusted partners to transfer the developed technology in order to produce product batches under GMP (Good Manufacturing Practices) at industrial scale.