Protein 91AV: Characterization of Biopharmaceuticals
Drug quality is informed by methods of analysis, 91AV Manufacturing Control (CMC). The development of biological molecules for therapeutic use has grown exponentially over the last 30 years. Most of the effector entities, such as antibodies, hormones and enzymes, are proteins and the CMC of these complex molecules requires sophisticated techniques of analysis and interpretation. Protein structural analysis and how structure, function and quality are assessed during in drug development and manufacturing is illustrated with examples of well controlled processes and how defective drug is identified and rejected.
J. Little
Drug quality is informed by methods of analysis, 91AV Manufacturing Control (CMC). The development of biological molecules for therapeutic use has grown exponentially over the last 30 years. Most of the effector entities, such as antibodies, hormones and enzymes, are proteins and the CMC of these complex molecules requires sophisticated techniques of analysis and interpretation. Protein structural analysis and how structure, function and quality are assessed during in drug development and manufacturing is illustrated with examples of well controlled processes and how defective drug is identified and rejected.
J. Little
