2013 Archived Content

August 21-22, 2013

Cambridge Healthtech Institute’s Inaugural
Rapid Methods to Assess Quality & Stability of Biologics

Improving Prediction and Screening


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Thursday, August 22

8:00 am Morning Coffee


Approaches for Analytical Assessment of Biopharmaceutical Quality 

8:25 Chairperson’s Remarks

Jennifer F. Nemeth, Ph.D., Principal Scientist, Biologics Discovery Program Leader, Biologics Research, Janssen Research & Development, LLC

8:30 Assessment of Vaccine Components and Recombinant Monoclonal Antibody Stability Using Biophysical Methods

Marina KirkitadzeMarina Kirkitadze, Ph.D., MBA, Deputy Director, Head, Biophysics and Conformation Unit, Biochemistry Platform Analytical R&D North America, Sanofi Pasteur Ltd. - Biography 

Secondary and tertiary structure of protein vaccine components and mAbs, as well as particulate formation is examined using a combination of various biophysical methods. These methods are applied at various stages of manufacturing that includes purified bulk concentrate and formulated product. Examples will be presented showing how a characterization package is used to assess process changes, stability, and lot comparability.

9:00 Methods and Approaches for Early Stability Assessment of Potential Biotherapeutics to Support Manufacturability Biography  

Patrick FlanaganPatrick Flanagan, Senior Research Associate, BioFormulations Department, Genzyme Corporation, a Sanofi Company

An understanding of protein stability for a series of potential biotherapeutic candidates is essential when assessing manufacturability. Such knowledge can identify candidates best suited to move into development or detect degradation issues which need to be addressed before such a transition can occur. This talk will focus on approaches and challenges in obtaining an early assessment of protein stability.

9:30 Analysis of Sub-Visible Particulates in Antibody-Maytansinoid Conjugates

Praval ShahPraval Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. - Biography 

Antibody-Maytansinoid Conjugates (AMCs) are administered intravenously and sub-visible particulate (SVP) levels need to meet compendial specifications. The relatively large volume requirement of the compendial light obscuration method (USP<788>) limits its use in early stage development. This presentation will focus on the evaluation of reduced injection volume light obscuration method for quantifying sub-visible particulates in AMC samples for early stage development.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Streamlining the Process for the Automated Assessment of Post-Translational Modifications in Biotherapeutics

Jennifer NemethJennifer F. Nemeth, Ph.D., Principal Scientist, Biologics Discovery Program Leader, Biologics Research, Janssen Research & Development, LLC - Biography 

A semi-automated system was previously developed that incorporates HPLC-MS and data-dependant acquisition experimental data with repurposed commercial proteomics software. This system was designed to facilitate the identification and delta change of defined post-translational modifications in stability-stressed samples of candidate biotherapeutics. Here we report on the development of new activities and processes to streamline the method, and to reduce the number of software programs required to achieve reproducible, automated results.

11:15 FEATURED PRESENTATION:

Introducing Rapid Analytical Techniques into the Commercial Quality Control Laboratory

Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc. - Biography 

Emerging technologies require much more effort to implement into a routine quality control laboratory. The design space of the analytical method should be characterized to predict the failure modes and variability of the assay over the course of different analysts executing the assay over many years. Examples such as SEC-UPLC and microchip based gel electrophoresis will be discussed.

11:45 Utilization of Process Analytical Technology (PAT) to Replace Fractionation in A GMP Manufacturing Setting

Stacey WilliamsStacey Williams, Associate Scientist, Process Development, Amgen, Inc. - Biography 

PAT utilization and implementation in a GMP manufacturing settings allows for real time decisions that will have a positive impact on product yield and quality while reducing labor requirements and production delays. This union between real time analytics and manufacturing is the new future.


12:15 pm Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

1:00 End of Conference



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