Conclusion
Table 2. Application of Assay Techniques
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Factors such as quality, time to market, and cost have forced an evolution of state-of-the-art analytical test methods. In
addition, changes in the regulatory framework, such as PAT and biogenerics, can also drive innovation in analytical development.
However, putting these techniques into routine use can be challenging. Some powerful state-of-the-art techniques are PCR and
MS. (The uses for these techniques and others in protein characterization can be found in Table 2.) New techniques require
evaluation and development to ensure that the data they provide is equivalent to that of more accepted and traditional methods,
but nothing can replace good scientific rationale and careful experimentation and testing.
Anita Bate, Ph.D., is a team member at Eden Biopharm Ltd, D5, Stanlaw Abbey Business Centre, Dover Drive, Ellesmere Port, Cheshire, CH65 9BF,
UK, 44 (0) 151.356.5632, Fax: 44 (0) 151.356.5633, anita.bate@edenbiopharm.co.uk
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