Dr. Ahmet Emin Atik
Department of Natural Sciences at Acıbadem University
Istanbul, TR
Biography
Dr. Atik earned his BSc, MSc, and PhD degrees in Chemistry from İzmir Institute of Technology (IZTECH). He completed his doctoral research in 2013 under the supervision of Prof. Talat Yalçın, with a focus on the gas-phase fragmentation chemistry of peptide ions using advanced mass spectrometry techniques. During his doctoral studies, he was a visiting fellow at Université Paris-Sud XI in the research group of Prof. Philippe Maître, where he investigated the structures of acetylated peptide ions using infrared multiphoton dissociation spectroscopy.
Following two years of postdoctoral research at the Biological Mass Spectrometry Laboratory of IZTECH, he joined the Biotechnology Department of Turgut Pharmaceuticals in 2015. There, he has held key leadership roles in protein analytics and quality control and currently serves as a Qualified Person (QP).
In parallel with his industrial responsibilities, Dr. Atik is an Associate Professor in the Department of Natural Sciences at Acıbadem University, where he contributes to education and research in biotechnology and analytical sciences. His research focuses on the physicochemical and functional characterization of monoclonal antibodies using state-of-the-art analytical platforms, with particular emphasis on biosimilar development, comparability, and quality assessment.
Title: State-of-the-Art Analytics in Biosimilar mAb Development: From Analytical Similarity to Clinical Confidence
Abstract
Biosimilar drugs are biological medicinal products that are highly similar to an already approved reference product, with no clinically meaningful differences in terms of quality, safety, and efficacy. Today, the development of biosimilar monoclonal antibodies (mAbs) has entered a new era where advanced analytical characterization has emerged a key role in building regulatory confidence. State-of-the-art analytical technologies enable highly sensitive and comprehensive assessment of biosimilarity across critical quality attributes (CQAs). Recent draft guidance from the U.S. Food and Drug Administration (FDA) highlights that robust analytical similarity, when supported by clinical pharmacology studies, may be sufficient to demonstrate biosimilarity without the need for a Phase III clinical efficacy study (CES).
This presentation will highlight how state-of-the-art analytical platforms—including high-resolution mass spectrometry, post-translation modification analysis, glycosylation and charge variant profiling, size heterogeneity evaluation, higher-order structure characterization, and functional and binding assays—collectively establish a detailed similarity fingerprint between biosimilar and reference mAbs. These orthogonal analytical approaches are essential for defining CQAs and enabling comprehensive comparability assessments, including evaluations under forced degradation conditions.
In summary, the talk emphasizes how analytics-driven development strategies are reshaping biosimilar development steps and regulatory expectations. This approach supports a more efficient and patient-centered approval process by reducing the costs of clinical studies and accelerating patient access to high-quality biosimilar medicines.