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