Analytical Development

High quality analytical development is essential to the success of any drug development effort and enables the characterization of the drug for the required attributes of identity, purity, strength, potency and safety. A focus on robust analytical development methods that are suitable for validation and readily transferable is imperative. Also, development scientists must produce development and validation reports that document all the relevant method information and are suitable for inclusion in the CMC section.

Development scientists possess substantial experience and expertise in the development, validation and transfer of analytical methods – be it a “stand-alone” method that provides a key piece of information in a project, or an integrated suite of methods for support of a comprehensive development project.

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Analytical Development Techniques Utilized:

• CD, DSC, FTIR, Fluorescence, DLS
• UV-Vis Spectroscopy
• LC-MS (ESI-TOF, MALDI-TOF), LC-MS/MS (qTOF), GC-MS
• HPLC (IEX, RP, HIC, SEC)
• Peptide Mapping
• SDS-PAGE, IEF, and CE (CZE, CGE, cIEF)
• ELISA, Biacore

Bioassay Development

The complex structure of biotherapeutic drugs translates into complexity of biotherapeutic function. In an effort to accurately capture the subtle functional changes for a biotherapeutic, bioassays are increasingly applied over more traditional biochemical binding assays in order to capture functional complexities otherwise lost. Due to the wide appeal of bioassays, there are ever-increasing efforts to apply them at many stages in the drug development pipeline – including target discovery, lead optimization, preclinical development, and as potency assays for batch release.

The development and validation of bioassays requires careful attention to detail due to the many factors involved in their development. Research scientists provide a wealth of experience for the rapid development, validation and transfer of bioassays designed to give meaningful indications of biotherapeutic function.