Drug Development Solutions

Drug Development Solutions

  • Route scouting; develop, optimize & scale-up with all requisite analytical development & regulatory support till process validation & filing of NDA
  • QbD based process development; Process safety and hazard assessment; Critical parameter evaluation, process validation & stability studies
  • Ownership of process with R&D till process validation & transfer to the plant
  • Fee for service / FTE Business Model; IP belongs to customers
  • State of Art Infrastructure including dedicated lab-space for handling of potent compounds
  • Electronic Lab note books
  • Scifinder®; Reaxys; Derwent World Patent Index on Delphion®; ACS® journals; Access to libraries at local premier academic institutions

Analytical Support

  • Method development & transfer
  • Method validation & verification
  • Stability studies
  • Polymorph identification, studying polymorph transformation, Amorphous content estimation etc.
  • Isolation and characterization of impurities
  • Reference standard characterization
  • Multiple State-of-Art Analytical Laboratories
  • Expansive stability chambers at both Hyderabad & Vizag – stability samples stored at the location of manufacture
  • General Analytical facilities such as HPLCs; NMR; GC-HS; GC-MS; LC-MS; UPLC with all required detectors including CAD; KF-Auto-Titrators; Particle Size Analyzers; TOC Analyzer; UV-Vis etc.
  • Solid State studies: NMR with Solid State capability; XRD; FT-IR; DSC & TGA
  • ICP-MS; MPLC; Prep HPLC; AAS; CE; UPLC-DAF-MS/MS etc.

Backward Integration – KSM and Intermediates

  • In addition to supporting Drug Development manufacturing efforts of our customers, Laurus also offers support to address the current challenges (uncertainty and cost increase) faced by our customer base, with regard to starting material supply from certain geographies, regulatory compliance filing risk associated with certain suppliers
  • Laurus has set up dedicated Development team for in-house development and production of KSM and Intermediates.

Quality by Design:

  • Generation of experimental designs during chemical process development utilizing software tools such as MODDe.
  • DoE routinely used during the pre-tech-transfer phase of identification of Critical process meters, process validation etc.
  • Access to the expertise of experienced consultants with authority on use of advanced experimental design linking DoE with PCA for efficient reaction development
  • Extensive study of the laboratory processes w.r.t. their scalability using Syrris and OptiMax vessels & interpreting the data generated using Visimix software
  • Continuous process improvement either leading to process validation &/or post process-validation by way of analysis of the data generated through multiple campaigns

Genotoxic Impurities evaluation:

  • Experience in evaluation of potential genotoxic impurities in synthetic routes
  • Use of Derek Nexus software for structure based toxicity prediction

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