Protein Formulation and Delivery

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As most macromolecule drug products are injectables, a thorough depiction of structural stability during storage is required during development.

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In their article, Zheng et al investigate the influence of pH and buffer species in an IgG 1 subtype therapeutic monoclonal antibody A. While this research highlights the need for specificity in monoclonal antibody characterization of degradation, the design used and techniques employed could be useful for investigating similar drugs. Finally, an approach to study supramolecular inclusion complexes using lab techniques and in silico calculations is included in this theme and could be used in macromolecule drug development. The continued growth in the macromolecule drug field will move forward new entities for formulation and thus further push the drive for development of alternative dosage forms.

While much is known in formulating and developing injectables, few successful medicines for alternative routes have been approved and are marketed. Research and innovation is expected to continue bringing new molecules to formulate, and the research in alternative routes of administration is likely to result in more availability of macromolecule drug products. To read the full content, please log in with your AAPS member username and password. Sign In Not a member? Learn more and join today! AAPS Newsmagazine helps pharmaceutical scientists excel in their jobs by providing current science, news, career advice, member recognition, AAPS offerings, and other valuable contemporary information.

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PROTEIN CRYSTALS - Reshaping Traditional Biotherapeutic Formulations

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Vaccine Formulation and Delivery Systems Unit

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Protein Formulation and Delivery, Second Edition Drugs and the Pharmaceutical Sciences

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Noninvasive Strategies for Systemic Delivery of Therapeutic Proteins — Prospects and Challenges

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