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Cambridge Healthtech Institute’s Inaugural
Early Analytical Development for Biotherapeutics
Optimizing the Selection and Performance of Preclinical Analytical Studies
Part of CHI’s 6th Annual The Bioprocessing Summit

August 20-21, 2014 | Renaissance Boston Waterfront Hotel | Boston, Massachusetts


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 


Thursday, August 21

8:00 am Registration and Morning Coffee


EARLY DEVELOPMENT ASSAYS

8:25 Chairperson’s Remarks

VijayDhawanVijay Dhawan, Ph.D., Scientist, Bioanalytical Development, Genzyme





8:30 Insights from Recent Regulatory Filings and Pre-IND Meetings with FDA

NadineRitterNadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC





9:00 Streamlining Antibody Characterization by Simultaneously Monitoring Multiple Product Quality Attributes

Catherine EakinCatherine Eakin, Ph.D., Senior Scientist, Amgen

Process control of biopharmaceuticals is critical for ensuring product quality, safety and efficacy for patients. Owing to their complexity, large molecules inherently have heterogeneity; however, throughout development multiple analytics are employed to define process consistency. We utilize a single mass spectrometry based method that can simultaneously measure multiple individual product quality attributes. This approach is more efficient than conventional characterization strategies and provides product characterization at the residue specific level.

9:30 Analytical Characterization of Inline claMP Tag Protein-Metal Conjugates

JenniferLaurenceJennifer S. Laurence, Ph.D., Associate Professor, Pharmaceutical Chemistry, University of Kansas

Metals are central components of imaging diagnostics, chemotherapeutics, and biotechnology reagents. Synthetic chelators are used to bind metals and are chemically conjugated to proteins for targeted applications. Metal-binding peptide tags offer a linker-less alternative. Both approaches are much more effective with lanthanides than transition metals. We developed the metal abstraction peptide (MAP) chemistry and engineered the linker-less claMP Tag to enable usage of more biocompatible metals. Characterization of these inline conjugates will be presented.

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

10:45 Key Quality Attributes during the Early Stage Development of a Biologic – What Is Important for this Stage of the Program?

VijayDhawanVijay Dhawan, Ph.D., Senior Scientist, Bioanalytical Development, Genzyme

During the early stage development of a biologic, selective preliminary critical quality attributes (CQAs) should drive the initial analytical characterization of the molecule. It is of paramount importance that these efforts focus on attributes with a possible linkage to the clinical outcome. Biological activity, identity and purity are examples of few such attributes. The analytical efforts to characterize these attributes can serve a longstanding purpose during the lifecycle management of the molecule. The choice of these attributes and the associated analytical tools will be discussed.

11:15 Generic vs. Specific Immunoassays for Quantification of Biotherapeutics in Late Research and Early Development

Kelly LoyetKelly Loyet, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Research, Genentech

It is necessary to evaluate potential biotherapeutics with preclinical pharmacokinetic (PK) assays. These assays measure the concentration of biotherapeutics in a biological matrix. Commonly, quantitative immunoassays are developed with analyte-specific reagents, although it is also feasible to use a generic approach with reagents that could quantify any biotherapeutic in its class. These strategies may also be complementary to further explore or confirm unexpected results.

11:45 The Roles of Analytical Development and Protein Characterization in Late Stage Discovery Research and Early Stage Development

AndrewDowneyAndrew Downey, Ph.D., Researcher, Chemistry, University of Massachusetts Lowell

Analytical methods examining the critical structural and functional aspects of protein products should be established by late stage discovery research and early stage product development. Examples of analytical studies discussed include characterization of structural isoforms, assessment of functionality and identification of degradation pathways, with a focus on evaluation of ‘manufacturability.’ Though encompassing various factors, early recognition of drawbacks to effective protein manufacturing ultimately contributes to product quality and economy of development.

12:15 pm End of Conference 


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