Introduction
Disease burden Countermeasure development Estimated 1.7 million people died from tuberculosis in 2009 [15] “Funding for [tuberculosis] control continues to increase and will reach almost US$5 billion in 2011. ……
A New Method of Differentiation Between a Biological Attack and Other Epidemics
Parameter Swine flu Amerithrax Kosovo tularemia Sverdlovsk anthrax BA NE NR AR BA NE NR AR BA NE NR AR BA NE NR AR Perpetrator Source/Reservoir of infection Sophistication 0…
Techniques for Higher-Order Structure Determination
Fig. 3.1 A Jabloński diagram depicting fluorophore absorption, radiative, and non-radiative relaxation pathways. Singlet ground, first, and second electronic states are represented by S 0, S 1, and S 2….
Biophysical Analysis in Support of Development of Protein Pharmaceuticals
Fig. 8.1 Schematic of overall protein stability The choice of which biophysical methods to use is dictated by the types of studies and specific requirements that support protein drug development….
Application of Biophysics in Formulation, Process, and Product Characterization: Selected Case Studies
Fig. 7.1 Far-UV (a) and near-UV (b) CD spectra of pilot-scale and full-scale drug substance lots in clinical and commercial formulations, respectively. Lots 1 and 2 are pilot-scale lots; Lots…
Case Studies Applying Biophysical Techniques to Better Characterize Protein Aggregates and Particulates of Varying Size
Fig. 9.1 Analytical characterization of IgG1 monoclonal antibody solutions containing soluble aggregates measured by orthogonal methods, SE-HPLC (a, b, c) and SV-AUC (d, e, f). Protein aggregates of varying size…
Qualification of Biophysical Methods for the Analysis of Protein Therapeutics
Fig. 5.1 (a) Far-UV CD spectra of protein 1–4 (spectral similarity compared to that of protein 1 is 100% protein 1; 5.0% protein 2; 44.9% protein 3; 28.7% protein 4)….
High-Throughput Biophysical Approaches to Therapeutic Protein Development
Fig. 2.1 Representative differential scanning fluorometry spectra obtained with a therapeutic protein on 96-well plate filled with different formulations for each well. Fluorescence intensity in relative fluorescence units (RFU) is…
Investigation of Nonconformance During Protein Therapeutic Manufacturing
Fig. 10.1 Microparticle analysis procedure The majority of the microparticles can be isolated through filtration using filter appropriate for the planned analysis. A gold-coated membrane filter (Rapid-ID, Berlin, Germany) facilitates…
Application of Biophysics to the Early Developability Assessment of Therapeutic Candidates and Its Application to Enhance Developability Properties
Instabilities 1. Physical • Conformational stability Thermal denaturation Cold denaturation Pressure-induced denaturation Chemical denaturation • Colloidal stability • Surface/interfacial-induced denaturation 2. Chemical • Deamidation • Asp isomerization • Fragmentation •…
