White Paper

Crystalomics: A Pathway Forward For Protein Crystallization

Source: Ajinomoto Althea, Inc.
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Protein-based therapeutics, specifically monoclonal antibodies (mAbs), have become the focus of pharmaceutical R&D over the last decade. While these biologics offer many possibilities when it comes to treating a variety of diseases, they also present considerable challenges during development. This is because, traditionally, protein-based therapies are delivered at high concentrations due to their size, biochemical complexity, and low bioavailability. These higher concentrations can increase solution viscosities, resulting in the possible formation of aggregates, which are associated with altered biological activity and increased immunogenicity. In addition, most protein-based biologics are administered via parenteral routes, making it necessary for patients to make long and expensive trips to a clinic to receive treatment. All of these factors combined make manufacturing and delivery of protein-based therapeutics very difficult. If these drugs could be produced at lower suspension viscosities, then a lower volume could be used, making subcutaneous delivery possible; this would also significantly reduce the risk of aggregates. Now, a treatment that typically requires an hour in a clinic could potentially become a simple injection at home.