Process R&D and cGMP Manufacturing
Syngene has comprehensive Process R&D (PRD) and cGMP manufacturing capabilities to support the CMC campaigns of NCE programs. Our PRD facilities inlcude Syrris Atlas automated reactor system and Filtration study equipment.
Process Research and Development
Syngene’s process research and development team comprises of chemists, engineers and process analysts with expertise in every phase of process research.
Some of the key equipments we have are listed below:
- Syrris Atlas automated reactor system
- Radley’s carousel system
- Glass reactors, 100mL to 20L
- Easy max 102 for parallel synthesis
- Process engineering lab
- Laboratory distillation set up: Regular and packed columns
- QVF all glass reactors: 5L to 20L
- Flow process equipment
- Filtration study equipment
- Hazard Evaluation: RC1e; DSC & TGA
Syngene’s cGMP manufacturing facility is spread across 60,000 sq. ft. We have over 36 reactors ranging from 20L to 3000 L having capacities in SS 316 L, glass lined, Hastelloy. We are equipped with Automated systems like Building Management System (BMS) and Distributed Control System (DCS) to manage facilities. Our cGMP manufacturing facilities are designed with multiple clean rooms with separate wet & dry processing areas of which 4 are class 100,000 (ISO-8) and 1 is class 10,000 (ISO-7).
- High Pressure Reactions: We have capabilities to operate up to the pressure of 40 kg/cm² which includes the high end gas induction type of hydrogenator. In addition, we have capabilities to undertake acidic hydrogenation reactions.
- Crayogenic Reaction: We have diverse capabilities with multiple crayogenic reactors ranging from 20L to 1500L capable of achieving temperature up to (-) 100ºC.
- Syngene has capabilities for freeze drying up to (-) 55ºC by using tray type lyophilizer in a classified area.