Process Chemistry
Adgyl Lifesciences, in collaboration with our partner laboratory, Eurofins CDMO India, provides end-to-end process research and development services. Our capabilities span kilogram-scale synthesis to support efficacy and toxicology studies, through to multi-hundred-kilogram cGMP scale-up for clinical development and commercial manufacturing.
Capabilities Include:
Our scientists and process engineers have strong expertise in developing safe, efficient, and scalable routes for complex molecules, supported by capabilities including impurity identification, spike and purge studies, in silico assessment of potential genotoxic impurities (PGIs), analytical method development, process safety studies, and polymorph and salt screening. We also apply Quality-by-Design (QbD) principles for robust late-phase process development.
Process chemistry services are offered through both fee-for-service (FFS) and full-time-equivalent (FTE) models, serving academic institutions, biotech companies, large pharmaceutical organisations, and agrochemical clients. Backed by QP-audited cGMP facilities, we deliver efficient, reliable, and cost-effective end-to-end CMC support.
Process Chemistry Services Include:
- Gram to multi-hundred-kilogram scale synthesis (non-GMP & cGMP)
- Focused libraries, Scaffolds, building blocks and Intermediates
- Reference and standard compounds
- Metabolite and impurity synthesis
- Stable label compounds (deuterium labelled)
- Scale-up support to DMPK and Tox studies
- Design and demonstration of innovative and robust synthetic routes
- Phase appropriate process development and optimisation
- Impurity isolation, identification and synthesis
- Use of systematic methodologies such as Design of Experiments (DoE) and Quality by Design (QbD)
- To obtain high quality, process optimisation to identify critical process parameters (CPP)
- Process validation studies to meet specified quality parameters
By using Accelerated Reaction Calorimetry (ARC) and Differential Scanning Calorimetry (DSC)
- Potential exothermic and runaway reactions,
- Explosive reactions,
- Thermal Properties of samples
- Unexpected release of toxic or flammable gases etc
- Seamless technology transfer from lab to pilot-plant and to commercial plant for large-scale manufacturing
- Modern equipment, utilities, and state-of-the-art scale-up capabilities
- Polymorph screening, identification and evaluation
- Comprehensive salt, hydrate or co-crystal screening studies
- Using LC-MS/ MS and NMR spectroscopy
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible, and timely study execution
High-quality data generation aligned with regulatory & scientific requirements
End-to-end support from model selection to data interpretation
Connect with our expert team today to discuss how we can support your in vivo pharmacology and imaging needs.
what people ask
Frequently Asked Questions
What range of scale can you support?
We support synthesis from gram scale to multi-hundred-kilogram batches (non- GMP and cGMP).
Do you handle end-to-end process development?
Yes, from route scouting and early development to cGMP scale-up and tech transfer.
Do you offer custom synthesis services?
Yes, including intermediates, building blocks, reference standards, and labeled compounds.
Do you support technology transfer?
Yes, seamless transfer from lab to pilot and commercial manufacturing.
Can you synthesis and characterise metabolites?
Yes, with full structural characterisation using advanced analytical tools.
