Biophysical Characterization of Biopharmaceutical Products


The use of biophysical critical in addressing some of the development challenges for biopharmaceutical drugs.

By Yongchao Su, Ph.D.; Jing Song, Ph.D.; Katelyn J. Smith, Ph.D.; Elizabeth E. Pierson, Ph.D.; Jason K. Cheung, Ph.D.; Wei Xu, Ph.D.; and Allen C. Templeton, Ph.D., at Merck & Co., Inc.

Biological products have seen increases in both utility and complexity in recent years. Development of peptide, protein, and antibody therapies can provide treatment to patients suffering from a host of conditions including autoimmunity and cancer. Delivery of such therapeutics presents the patient with benefits over traditional small molecule pharmaceutical drugs including more target specificity resulting in fewer off-target effects and associated toxicities. Additionally, new biotherapeutic modalities such as intracellular targeting peptides, Fc-fusion proteins, nanobodies, bispecific monoclonal antibodies, and antibody-drug conjugates may offer improved specificity or potency. Unfortunately, biotherapeutic products have complicated degradation pathways including both chemical degradation (e.g., deamination or isomerization) and physical instability (e.g., aggregation), which may result in significant challenges during the biopharmaceutical product and process development.

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January 2018

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