Research & Development

Drug Product Development:

Drug Product Development team at Enzene has highly experienced staff to carry out all types of experiments related to pharmaceutical development of peptide and protein based therapeutic products in the form of sterile liquid, lyophilized, novel formulations, high concentration long acting formulations. DPD is focused towards pre-formulation studies of drug substance like solubility, pH dependent degradation studies, forced degradation studies, effect of temperature, pH, humidity, oxygen, light, freeze thaw studies, container closure compatibility, which are required for evaluation of a product at preclinical as well as clinical stage of development. We also work on various combination platforms such as vials, PFS, cartridges, auto injectors and pen devices.

Capabilities:

  • Formulation development of dosage forms for stability studies at accelerated, real time and stress conditions.
  • Support drug product storage period during pre-clinical, clinical studies and for commercialization to fulfill various regulatory filings.
  • Develop non infringing formulations for bio-therapeutics.
  • Exploring novel delivery systems such as patch and pen device.

Infrastructure:

  • HPLC
  • UPLC,
  • LC-MS,
  • DSC,
  • Lyophilization
  • Fully monitored stability chambers
  • Karl Fisher