Phase appropriate capabilities for analytical method development, optimization and validation


We have analytical capabilities and expertise that encompass a wide range of technologies to support all stages of product and process development. These have been applied to a variety of biomolecules including recombinant proteins, plasmids and polysaccharides. Method development and validation as well as process development support is the daily business of the microbial analytical services. These methods have also been successfully used to support license applications following product specific validation.

Lonza’s range of analytical services include:

  • HPLC & UPLC systems (UV, DAD, CAD, MALS, Fluorescence)
  • UV/VIS and slope spectroscopy
  • Protein content (BCA, Bradford, Lowry)
  • CE-SDS, CZE, cIEF 
  • SDS-PAGE and western blotting
  • qPCR, Picogreen and/or threshold 
  • Immunoassays – ELISA (titer, HCP, potency)
  • Traditional approach on MTPs
  • High throughput (TECAN Freedom Evo)
  • High sensitivity protein-PCR (ProteinSEQ™)
  • Bioburden and endotoxin

Experience:

  • Method development
  • Technology transfer toward cGMP manufacturing
  • DoE based development for improved sensitivity
  • Stability studies
  • Reference standard characterization
  • Validation, formal transfer of methods