Drug Substance Development
Our R&D centre has been designed to accelerate development of innovative processes for niche fermentation-based small and large molecules. With integrated upstream, downstream, and analytical capabilities, we have the right infrastructure to develop and scale up complex biochemical processes at the laboratory stage.
Advanced Strain Engineering Capabilities
We have in-house capabilities for strain improvement through both targeted and random mutagenesis approaches. Random mutagenesis followed by targeted mutagenesis—post identification of metabolic bottlenecks using bioinformatics tools such as Metabolic Flux Analysis, genomics, and transcriptomics—is employed to develop high-yielding mutant strains with low impurity profiles.
A novel screening assay has been developed to significantly reduce lead identification timelines and accelerate strain selection.
Upstream Process Development & Optimization
Process development and optimization are carried out using statistically driven Design of Experiments (DoE). AI/ML-based simulation platforms are being leveraged to reduce development timelines and enhance predictive optimization.
Integrated Scale-up Infrastructure
- 10 L Fully Automated Sartorius Bioreactor
- 50 L Fully Automated Stainless-Steel Bioreactor
- Controlled incubation systems (orbital and static)
- Dedicated inoculum development and media preparation facilities
Key Technical Areas
- Media and nutrient optimization through DoE and ANN models
- Inoculum development and scale-up
- Batch and fed-batch fermentation process development and scale-up
- Yield and productivity enhancement
Downstream Process Development
We have in-house capabilities for the design and optimization of recovery and purification processes to achieve high product yield, desired purity levels, and consistent process performance suitable for scale-up and manufacturing transfer.
Downstream Infrastructure
- High-speed centrifugation systems
- Peristaltic and vacuum transfer systems
- Ultrasonication
- Rotary Evaporator
- Fume Hood for safe handling of solvents and volatile materials
- Bench-top, Glass vessel, Crystallizer (1 L reaction volume)
Key Technical Areas
- Product extraction and purification process development
- Recovery optimization and yield improvement
- Process reproducibility studies
Analytical Method Development
Our analytical laboratory supports development of precise, reliable, and regulatory-compliant testing methodologies.
Analytical Infrastructure
- Agilent HPLC System
- Preparative HPLC
- Kjeldahl nitrogen estimation system
Key Technical Areas
- Method development and optimization
- Assay and impurity profiling
- Raw material and finished product analysis