18 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m
Analytical Methods
• Ensuring that all data supporting the assay de-
velopment are reviewed and verifiable
• Ensuring that data reduction is based on trans-
parent and sound calculations
• Making sure that documentation supporting
the method development is captured in real
time
• Making sure that development details are leg-
ible, if captured on paper, complete, and easy to
follow.
If the development of an analytical method is
to be pursued based on the QbD concept, as it is
strongly recommended, one needs to follow the
multiple discrete steps outlined in Figure 1.
Unlike the traditional analytical method de-
velopment approach, where method variables are
Figure 1: Diagram of method development by quality by design (QbD). DoE is design of experiment.
Table I: Analytical methods and product quality attributes.
Product attribute Analytical methods
Identity N-terminal sequencing, peptide mapping, enzyme-linked immunosorbent assay (ELISA), Western blot, high-
performance liquid chromatography (HPLC), electrophoresis
Aggregation High performance/ultra performance size exclusion chromatography (HP/UP-SEC), analytical ultracentrifugation
(AUC), field-flow fractionation (FFF)
Purity Reverse-phase (RP)-HPLC, hydrophobic interaction chromatography (HIC), capillary electrophoresis sodium
dodecyl sulfate (CE-SDS), Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)
Strength Absorbance, colorimetric assay, ELISA
Potency Cell-based assay, ELISA, surface plasmon resonance (SPR)`
Particulates Light obscuration (HIAC), microfluidic imaging (MFI), Coulter counter
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