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
— Professor Mat Upton, CTO, Amprologix Ltd“Ingenza has an excellent and highly collaborative approach. We feel this cooperation has been more productive than the kind of relationship we could have realised with other companies, who might have attempted this work as a service contract.”