Delivering the Added Dimension in Drug Discovery Services
Taking your drug candidate to GLP TOX and CDMO needs an effective transition from the medical 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 program. Our 4D concept, which puts time at the forefront of what we do while ensuring high–quality product and safe operations, is a strong driver in considering us for your scale-up requirements.
PRD and Manufacturing Services
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:
Process design and optimization
Development and standardization of synthetic steps considering scalable manufacturing needs
Analytical method development and stability studies
Salt screening and polymorph studies
Transfer of process technology to pilot plant for advanced molecules
Biosys has a state-of-the-art cGMP pilot plant facility (approved by DCGI, India and global pharma) to cater to multi-kilogram manufacturing for supporting GMP production and processing of intermediates and final API for animal toxicology or Ph-I/II clinical material.
State-of-the-art 5000ft2 GMP pilot plant facility
ISO-8 (Class:100,000) clean rooms for complete manufacturing operations and ISO 14001:2015 for environment management system
ISO 9001:2015 certification
Multi-product manufacturing; Temperature range: – 90°C to 200°C; Batch size: 500g~10kg
Reactor Size: 20L to 100L; Glass / SS
Well-established kilo laboratory for the synthesis of compounds in multi-grams to kilograms level
Kilo lab with capacity up to 200L scale reactors with distillation facility
Equipped with centrifuge, Nutsche pressure filter, vacuum ovens for filtration and drying
Other facilities include chromatographic columns and high capacity (25L) rotavapors from Buchi
Dedicated QC lab for process control
Dedicated high-potency laboratory with 20L all glass reactor and facility to carry out small scale synthesis of high-potency molecules
Jubilant Biosys in partnership with our parent Jubilant Life Sciences can accelerate your candidate through contract manufacturing and development, driving innovative partnerships across the value chain.
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