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Your partner in science for end-to-end CRDMO solutions

Contract Development and Manufacturing 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 highquality product and safe operations, is a strong driver in considering us for your scale-up requirements.

CDMO Circle Contract Manufacturing

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:

  • Route scouting
  • Process design and optimization
  • Development and standardization of synthetic steps considering scalable manufacturing needs
  • Synthetic demonstration
  • Scale-up manufacturing
  • Analytical method development and stability studies
  • Salt screening and polymorph studies
  • Transfer of process technology to pilot plant for advanced molecules

GMP Services

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.

  • 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
  • Walk-in-hoods
  • 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
integrated cdmo project management

About Jubilant Biosys

Jubilant Biosys, in partnership with our parent Jubilant Pharmova, can accelerate your drug candidate through end-to-end development and manufacturing, driving innovative partnerships across the value chain. As a leading Contract Development and Manufacturing Organization, Jubilant Biosys help biopharma companies to transition swiftly from the drug development stage to clinical stages with flexible and strong scale-up capabilities.

We are dedicated to providing you with comprehensive solutions for preclinical & clinical outsourcing to ensure the well-integrated execution of your projects into the clinical phase. If you are looking for quality solutions incorporated with the best practices in the drug development and manufacturing domain, feel free to contact us. We will be happy to answer your queries.