Your global leading partner in science for end to end CRDMO services
Taking your drug candidate to GLP TOX and CDMO needs an effective transition from the medicinal chemistry phase to early scale-up without taking more time than absolutely necessary. Biosys has set-up a dedicated PR&D team along with a GMP pilot-scale clean room which provides a strong foundation for rapid scale-up and delivery of key milestones for your contract development and manufacturing program. Our 4D concept, which puts time at the forefront of what we do while ensuring high
Biosys has comprehensive process research and development (PRD) and manufacturing capabilities to support the early CMC campaigns of NCE programs up to phase 2. These combined capabilities ensure well-integrated execution of projects into the clinical phase at competitive rates.
The main challenges in transitioning a MedChem route to a larger-scale requirement is to evaluate each project, process separately, decide how best to safely proceed and at what level of ‘fit-for-purpose’ development.
Our PRD Capabilities:
Biosys has a state-of-the-art cGMP pilot plant facility (approved by DCGI, India and global pharma) to cater to multi-kilogram pharmaceutical development and manufacturing for supporting GMP production and processing of intermediates and final API for animal toxicology or Ph-I/II clinical material.