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, 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
— Dr John Runnacles, Business Research Director,Mitsubishi Chemical Methacrylates“We value our multi-year relationship with Ingenza, who have shown great capability and flexibility to help us successfully progress our technology development programme.”