Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization

Classification of Protein Aggregates1

“…In this case, the core material is nonproteinaceous and the protein does not show changes in the secondary structure when investigated by solid-state circular dichroism, and dissolves readily upon placement into physiological buffers. 17 There are several reports in the literature of foreign material such as glass and stainless steel acting as sites for protein adsorption and/or as nucleation sites for protein aggregation in the bulk. Tyagi et al 18 described the shedding of nanometer and submicrometer particles of stainless steel from mechanical pumps, resulting in submicrometer to micrometer (Coulter counter) heterogeneous aggregates containing protein and metal, where the protein has a partially unfolded structure.…”

Ongoing Challenges to Develop High Concentration Monoclonal Antibody-based Formulations for Subcutaneous Administration: Quo Vadis?

“…In addition, Bechthold-Peters et al have discussed other protein drying techniques, e.g., supercritical fluid drying, that may be useful to prepare protein powders for this application. 46,47 Alternatively, the formation of solid mAb crystals has been successfully used to develop highly concentrated mAb suspensions that have been tested in preclinical and early clinical development. A few (small) companies specialize in pushing this protein crystallization concept for HCAF.…”