The Analytical Development Unit focuses on development and improving assays that are supporting the process development and quality control unit. The unit is primarily involved in developing methods that can be used to evaluate identity, purity, and stability of the target products and that can be used as molecule stability indicators. The unit focuses on the characterization of molecules, degradation pathways and defines critical quality attributes in a phase appropriate context. The unit is involved in process comparability studies and coordinates analysis of in- process and product related impurities as needed.
Among the methods used are reverse phase HPLC, size-exclusion HPLC, SDS–PAGE, and Dynamic light scattering. The unit works also with academic collaborators to design and implement novel assays which can aid in determining the best formulation conditions for stability of drug substances and drug products developed by the program.
The Process Development Unit has a formulation room, plus shared space in Texas Children's Hospital Center for Vaccine Development.
The major equipment include the a Alliance and Waters HPLC system, a Wyatt HPLC Light Scattering Detector, a Spectra M3 Plate Reader, a Bio-Rad GS 800 Densitometer, Charles River Endosafe PTS system and a UPLC Waters Acquity.