Eurofins Advinus has a state-of-the-art manufacturing facility consisting of cGMP pilot plant, intermediate area and ISO class 8 clean rooms. It is equipped with world class infrastructure and reactors ranging from 0.16 KL to 4 KL with cumulative capacity of 44 KL.
We will be able to assist you in accelerating process development and scale-up under non-GMP and GMP compliance.
In addition to supporting early phase programs, including IND-enabling projects, our team will now be able to assist you in drug substance supply for clinical trials and commercial manufacturing. We endeavor to be your comprehensive service provider from bench scale to commercial scale manufacturing.
- Rapid piloting and scale-up
- Non-GMP and GMP manufacturing
- Supply of key RSMs (Regulatory Starting Materials)
- NCE/API manufacturing
- Process validation
- Stability studies
- Spread on an area of 8906 sq. m and built up area is 7845.43 sq. m
- Reactors – 0.16KL to 4KL
- Hydrogenation facility with 3 hydrogenators
- 2 Clean rooms – ISO class 8
- Batch size – 200kg (single batch – depending on dilutions)
- Environment management systems in place
- Stability chambers