Process
Research and
Development

Process Research and Development

GVK BIO offers extensive process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customization as per client’s needs to perform and progress in a collaborative partnership. We strongly believe in the importance of effective QbD during the development of late stage NCEs.

  • We involve cross-functional teams of process chemists, analysts, process engineers along with quality assurance, sourcing and manufacturing specialists during designing and development of the process
  • Teamwork enables us to achieve one of the elements of ICH Q 10, continuous improvement, within the boundaries of design space with minimum regulatory concerns
  • Our scientists are experienced in developing short and efficient processes for complex pharmaceutical products by utilizing in-house expertise and state-of-the-art technology

Our Chemistry capabilities:

  • Alkylation and acylation
  • Aminations (reductive/chiral)
  • Asymmetric hydrogenations (catalytic and hydrogen transfer)
  • Asymmetric synthesis
  • Cryogenic reactions
  • Grignard reactions
  • Organometallic (alkyl lithium/LDA)
  • Reductions using metal hydrides
  • Resolutions (kinetic and diastereoselective)
  • Boronic acids
  • Bio and chemo (using commercially available enzymes/catalysts)
  • Nitration
  • Cyanation
  • Diazotization
  • Azidation
  • Sulfonation
  • Halogenations

Other support services include:

  • Process validations, analytical method development and validation
  • cGMP manufacturing
  • CMC and other regulatory filings support
  • Impurity identification, characterization and synthesis
  • Stability studies
  • Cost Reduction by continuous process optimization, yield improvement and reducing cycle times

Whitepaper

Developability Assessment of Small Molecules

Download the Whitepaper