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Ann Clin Trials Vaccines Res. 2017 | Volume 1 Issue 2
Global Vaccines & Vaccination Summit & B2B
November 01-02, 2017 | Toronto, Canada
Comparability of biosimilar products: Insulin as a model
Maely Pecanha Favero-Retto
National Institute of Cancer, Brazil
Introduction:
Government initiatives at several nations have
motivated the development of biosimilar products. In contrast
to generics, biosimilar regulations require comparative
preclinical and clinical data because of uncertainties regarding
the level of characterization achievable, and the possible clinical
consequencesofdifferencesinphysical–chemicalcharacteristics,
such as amount of impurities. Protein therapeutics are a class
of products which have a complex three-dimensional structure
in solution whose integrity determines the biological activity,
clinical efficacy, and safety. Thus, it is highly desirable that
products from this class meet well-defined requirements for
structural integrity. The characterization of conformational and
oligomeric distribution of proteins is of paramount importance.
Methodology:
We have studied regular acting, wild-type human
insulin, and insulin analogues from different pharmaceutical
products directly from their final finished formulation by the
combined use of mass spectrometry, dynamic light scattering,
small-angle X-ray scattering, nuclearmagnetic resonance, single-
crystal protein crystallography and electrospray ionization-mass
spectrometry coupled to ion mobility spectrometry with the
aim to analyze structural information.
Findings:
We have made the combined use of modern state-of-
the-art structural techniques for the detailed characterization
of the chemical and structural integrity, accessing the correct
folding through the evaluation of the secondary, tertiary and
quaternary structural arrangement of the human insulin and
insulin analogues.
Conclusion & Significance:
These structural methods are
currently well-established, and they can be accessed in most
countries, in special those for the main pharmaceutical markets,
the Americas, Europe and Japan. It could be used in routine
evaluation of structural integrity and identity, as a part of
current or evolvingmethods aiming theminimization of animals’
requirement in routine quality control, in the development of
novel insulin products, or in future protocols for a thorough
comparability exercises between follow-on protein product and
a reference product.
Speaker Biography
Maely Pecanha Favero-Retto is graduated in Pharmacy from the Federal University
of Rio de Janeiro (1995), Master in Biological Chemistry from UFRJ (1999) and PhD
in Pharmaceutical Sciences from UFRJ (2013). She is specialist in Hospital Pharmacy
(2007) and Clinical Pharmacy (2015) by SBRAFH, with Executive MBA by the COPPEAD
Institute (2008). She is currently a Technologist in Hospital Pharmacy at the National
Cancer Institute and at the Hospital Municipal Miguel Couto. She is Professor of
the Multiprofessional Residency in Oncology at INCA and postgraduate courses and
President of the Brazilian Society of Hospital Pharmacy and Health Services (SBRAFH).
She has experience in the field of biological metrology with emphasis on the study of
biosimilar products.
e:
maely.retto@gmail.com