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.

Support for every stage of your product 

Get support for license applications following product specific validation for your products. Access our analytical expertise, including a wide range of testing capabilities for a variety of microbial derived products including bioconjugates.

Our analytical services include:

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

Our previous experience includes: 

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