Analysis and Assay Technologies

We design bespoke product assays, combining classical techniques with cutting-edge synthetic biology to precisely monitor biomolecule production. These provide a simple, reliable and practical means to identify top-performing production strains from libraries of variants and include:

Analytical method development

  • Comprehensive suite of fully serviced analytical instrumentation for biologics and small molecules analysis (HPLC, GCMS, HRMS-QTOF, LCMS, AKTA, Cedex Bio®)
  • Development of validated of custom-made analytical methods for in-process analysis and product release testing
  • Broad range of complimentary analytical methods required to establish target identity, quantity, purity and potency
  • Method development including key parameters such as specificity, linearity, LOD/LOQ, accuracy, precision, recovery and robustness
  • Rigorous QC and full traceability in accordance with company QMS procedures

Assay development

  • Design, development, optimisation and qualification of new assays and/or modification of existing assays for specific targets
  • Assay development for HTS (from hit-to-lead)
  • Design and development of bespoke assays for product characterisation (drug substance and drug product)
  • Development and qualification of assays for in-process control during upstream and downstream processes
  • Development and test performance of release assay

High-throughput screening

  • Automated platform for ultra high-throughput colorimetric/fluorometric detection of specific targets or biosensors for accelerated discovery
  • Media or growth-based selection schemes to optimise cell growth and recombinant protein production
  • Selection for resistance to toxic analogues of target products
  • Use of customised, easily removable, biomarker tag for convenient protein identification and streamlined purification

“I have worked with the Ingenza team for over a decade and have always appreciated their bioprocessing expertise and capabilities in support of several key projects both during my time at big biopharma and start-ups. I consider them a trusted and valued partner.”

— Fauad Hasan,former CEO, Bonti

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