Preformulation studies as an essential guide to formulation development and manufacture of protein pharmaceuticals.

摘要: Preformulation generally refers to a process in which bulk drug material is characterized sufficient extent that it can be converted pharmaceutically acceptable substance. In the case of conventional, small-molecule (nonmacromolecular) pharmaceuticals, this procedure usually accomplished high degree scientific rigor. For example, atomic level structures these compounds are known from combination X-ray crystallography, nuclear magnetic resonance (NMR), and mass spectrometry. Furthermore, sensitivity modern high-performance chromatography systems coupled spectrometric detectors often permits altered forms molecules simply detected identified. Unfortunately, increased complexity proteins, arising their large size higher order (secondary, tertiary, quaternary) structure does not yet permit more straightforward type analysis utilized for small applied. Nevertheless, still possible treat proteins primarily as chemical (rather than biological) entities through an understanding stability use complex array lower resolution methodologies.