2013 Archived Content
 

Day 1 | Day 2 | Download Brochure
Part One | Part Two | Short Courses 

Part One presents analytical case studies aimed at developing well characterized biotherapeutics with clearly defined quality features and reduced CMC liabilities. It covers higher order structures, sequence variants, impurities, charged isoforms, glycosylation and hot spots for stability, PK and biological activity for a range of products. The wide range of analytical technologies presented includes mass spec, proteomic approaches, and an innovative automated western blot technique. The functional characterization session includes bioassays for potency and binding, and a report of required standards from the USP.

Monday, March 11

12:00 pm Registration

2:00 Chairperson's Opening Remarks

Atanas Koulov, Ph.D., Group Head, Pharma Technical Development Europe (Biologics) Analytics, F. Hoffmann-La Roche Ltd.



ADVANCES IN ANALYTICAL TECHNOLOGY FOR CHARACTERIZATION 


» KEYNOTE PRESENTATION 

2:05 Analytical Tools for Characterizing Biosimilars, Biobetters and Next-Generation Antibodies with Enhanced Properties

Alain BeckAlain Beck, Ph.D., Senior Director, Antibody Physico-Chemistry, Centre d'Immunologie Pierre Fabre; Associate Editor, mAbs - Biography 

Multiple and complementary Mass Spectrometry (MS) methods are used at all stages of mAbs discovery, preclinical, and clinical development. MS methods are key techniques used for identification of "hot spots" which may be deleterious for stability, for PK, and for pharmacology properties. In the past decade, several hundred papers have been published on mAbs characterization by MS. As a result, deep insights into structure−function relationships of this leading class of pharmaceuticals have been gained. The early use in the R&D process of MS methods helps to optimize the structure of next-generation mAbs allowing the development of drug-candidates with reduced chemistry manufacturing and control liabilities.


2:35 An Evaluation of the Higher Order Structure and Biological Activity of an Oxidized IgG2 Monoclonal Antibody

John GabrielsonJohn Gabrielson, Ph.D., Principal Scientist, Analytical Sciences, Amgen, Inc. - Biography 

The effect of hydrogen peroxide oxidation on higher order structure and biological activity was assessed for an IgG2 therapeutic molecule. Even at high levels of oxidation (> 80%), the molecule's secondary and tertiary structures, as well as size variant distribution remained comparable to the control sample (5% oxidation). Conversely, relative binding to FcRn declined linearly with increasing methionine oxidation, and changes in thermal stability were detected at 40% oxidation, before in vitro potency was affected. This case study highlights the potential value of thermal stability measurements to predict domain-specific higher order structural changes that impact biological activity.

3:05 Speed Networking!

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing


CHARACTERIZATION OF SPECIFIC PRODUCTS 

4:00 Developmental Challenges with Multi-Target Recombinant Antibody Mixtures

Torben P. FrandsenTorben P. Frandsen, Ph.D., Vice President, Preclinical R&D, Antibody CMC, Symphogen A/S - Biography 

Recombinant antibody mixtures are presently being evaluated as drug candidates to treat serious indications especially within the oncology field. Quality characteristics and manufacturability of individual antibodies during the selection process for antibody mixture lead candidate is of fundamental importance to mitigate further CMC development. Assessment of individual quality characteristics is a key element for the successful development of project specific identity methods. This presentation will address the analytical and developmental challenges of antibody mixtures relative to monoclonal products and will shown different examples of used analytical methodologies.

4:30 Implementation of Automated Quantitative CE-Based Simple Western Technology for Vaccine or Therapeutic Protein Development

Richard R. RustandiRichard R. Rustandi, Ph.D., Research Fellow, Vaccine Analytical Department, Merck & Co. - Biography 

Many CE-based technologies such as icIEF, CE-SDS, and CZE are well established for analyzing proteins, viruses, or polysaccharides. For example, icIEF and CE-SDS are standard replacement methods in biopharmaceutical industries for tedious and labor intensive IEF and SDS-PAGE methods, respectively. Another important analytical tool for protein characterization is a Western blot. Currently, the procedure is very manual, laborious and time consuming. Here, we implement a new CE-based technology called Simple Western™ for performing automated Western analysis for vaccine and therapeutic protein programs. Applications of this new technology will be discussed with respect to protein quantitation, fermentation support, and mAbs screening.

5:00 Physicochemical Characterization of Antibody-Drug Conjugates

Kevin Anderson, Ph.D., Senior Principal Scientist, Analytical Biochemistry, Seattle Genetics, Inc. - Biography 

This talk will emphasize quality attributes, and describe analytical tools and analytical challenges unique to ADCs.


TOOLS AND APPROACHES FOR DETERMINING SEQUENCE VARIATION 

5:30 Use of the Stable Isotope-Tagged Reference Standard Method for Detection of Sequence Variants

David H. Lee, Ph.D., Principal Research Scientist, Process Sciences, Abbott Bioresearch Center - Biography 

Described in this presentation is a quantitative mass spectrometry approach, the SITRS method, which provides high resolution comparability of therapeutic proteins at the peptide level. Its utility in discovering and quantitating sequence variants will be discussed.

6:00 End of Day One of Analytical Characterization



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