Our site in Baroda has dedicated development laboratories with teams of chemists and analysts to look after your project and ensure a smooth transition from initial enquiry to the implementation the pilot plant scale-up and then on to commercial scale supply.
The laboratories are equipped with a wide range of equipment including standard laboratory flasks, carousels for multiple parallel work, RC1e and TSU for hazard screening.
Our analytical laboratories are equipped with the latest advanced instruments which helps in analytical method development and validation including method development for genotoxic impurities. Equipment includes:
- Headspace GC
- Ion chromatography and GCMS
Our Baroda pilot plant also consists of an intermediates area containing 20 reactors ranging in size from 100L to 1000L in a mixture of SS and glass lined MS, including a hydrogenation reactor and a Hastelloy reactor with a 250L capacity. There are two crystallisation / pure Class D areas containing 100L and 250L reactors of SS and glass lined MS. This pilot plant houses various types of filtration equipment and dryers, which helps to optimise process time. Temperatures can range from -20°C to 150°C.
Currently, this facility is only suitable for non-GMP use and scale-up, with plans to obtain regulatory approval as soon as possible. We can currently manufacture larger scale GMP starting materials from this location, with the ability to adopt a process and quickly scale up to produce ~10-100kg of product rapidly and safely. If the process has previously been run at our site in the UK, then tech transfer and pilot plant scale-up is managed by our team in Sunderland.
For GMP scale up/manufacture, we have two pilot plants in Ratlam.