The market for monoclonal antibodies (mAbs) is worth over $330 billion and is expected to more than double by 2030. As the research pipeline continues to grow, developers are facing numerous challenges, not the least of which is measuring and maintaining critical quality attributes (CQAs). One CQA that has drawn an increasing amount of attention…
Lyophilization: The basics
Lyophilization, defined as a freeze-drying process that removes water from a product after it is frozen and placed under a vacuum, is often messy, but filled with possibilities for potential applications. Some of the typical pharmaceutical products that would undergo lyophilization include bulk pharmaceutical/biopharmaceutical ingredient (chemical or biologics found in nature), protein, collagen, peptide, oligonucleotide,…