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BioPharm October eBook: Best Practices 2018

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18 BioPharm International eBook October 2018 www.biopharminternational.com Alexandr Mitiuc/adobe.com 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. P rotei ns must be c ha rac ter i zed at ma ny pha s e s of biopha r m ac e ut ic a l r e s e a rc h, development, a nd ma nu fac t u r ing, each with differing demands and requirements. Instrument capabilities—and limitations— inf luence the speed and success of development efforts. Researchers from biopharma, contract service organizations, and academia face challenges of select- ing and optimizing appropriate techniques for pro- tein characterization needs. E xper ts inter v iewed by BioPhar m Inter national 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 organizations, phases of development, and product t y pes, all expressed the desire for effec- tive tools to accomplish characterization studies throughout the development and manufacturing lifecycle. Michael Fleming, scientist and associate director of the analytical 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 RITA PETERS Biopharma Laboratory Best Practices Protein Characterization

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