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
