Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

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Page 41 of 45

42 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m ALEX ANDR MITIUC/STOCK.ADOBE.COM Protein Characterization P roteins must be characterized at many phases of biophar- maceutical research, development, and manufacturing, each with differing demands and requirements. Instru- ment capabilities—and limitations—inf luence the speed and success of development efforts. Researchers from biopharma, contract service organizations, and academia face challenges of se- lecting and optimizing appropriate techniques for protein charac- terization needs. Experts interviewed by Pharmaceutical Technology shared similar concerns about the need to conduct complex protein characterization studies under the pressures of tight timelines and urgency to get new drug products to clinic and approval. Representing different orga- nizations, phases of development, and product types, all expressed the desire for effective tools to accomplish characterization studies throughout the development and manufacturing lifecycle. Michael Fleming, scientist and associate director of the analyti- cal and pharmaceutical sciences group at Immunogen, leads a team that develops methods for characterization and testing antibody- drug conjugates (ADCs) and develops formulations. A major focus is the development of liquid and lyophilized dosage forms for drug substance and drug product development. Karan Shah, a principal development associate, analytical CMC and formulation, Immuno- gen, uses various biophysical techniques for higher order structure (HOS) analysis and characterization of antibodies and ADCs, along with stability testing for formulations, and analytical support. In a contract services environment, Brent Kendrick, vice-president R&D for KBI Biopharma, conducts biochemical and biophysical product characterization and analytical method development for large-molecule ADCs, peptides, and pegylated conjugates. Complex Protein Studies Demand Dynamic Techniques By adapting techniques from other sciences—and exploring better tools for biologics drug development—researchers are addressing challenges of protein characterization. Rita Peters

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