Process Development

In order to get the best yield and reduce costs, some process development is necessary to be able to efficiently scale up the chemistry from glassware into reactors. We have expertise in performing small scale synthesis and purification under a variety of conditions to develop a scalable process that will reduce the impurities and will optimize the output. This is also a critical step in the CMC development and will allow setting specifications for the API based on the process capabilities. Our goal is to develop “commercially viable“ procedures to support the early phase program and as the program proceeds, work to optimize the process parameters.

Special Technologies
We practice a wide range of complex, challenging chemistries at the reactor scale.

Low-temperature chemistry
Our cryogenic unit enables chemistry at temperatures as low as -80°C. This allows us to execute transformations with a high selectivity as well as a variety of organometallic reactions including butyl lithium, lithium diisopropylamide, lithium hexamethyldisilazane, lithium aluminum hydride and other complex hydrides.

Hazardous chemistry
Girindus can handle hazardous and highly reactive reagents/reactions. We have strict professional safety disciplines and facility configurations to perform such chemistry at the pilot plant scale. Girindus also has experience in screening and developing safer methods for scale up while delivering the initially desired amounts of API needed to keep your program on track.