Cambridge Healthtech Institute’s Second Annual

Analytical Characterisation of Biotherapeutics

Advances in Analytical Methods for Better Developability Assessment of Molecules

5-6 November 2015


Analytics play an important role throughout a product’s lifecycle, from candidate lead selection, to preparation for IND and characterizing for lot release. At Analytical Characterization of Biotherapeutics, we will take a closer look at advances in analytical technologies today that offer more accurate and faster methods to characterize structure-function relationships; examine developments in high throughput testing and bioassays for binding and stability; analyze post-translational modifications and glycosylation effects on quality and stability of biologics as well as characterize complex molecules and novel formats such as bispecifics, ADCs and fusion proteins.

Preliminary Agenda


NEW APPROACHES AND NOVEL TECHNIQUES FOR STRUCTURE-FUNCTION AND CQA DETERMINATION

Massive De Novo Sequencing of IgG Variants in Human Blood by Mass Spectrometry

Roman A. Zubarev, Ph.D., Professor and Head, Department of Medical Biochemistry & Biophysics, Karolinska Institutet

Biophysical Characterisation for Selection of Robust Humanised Therapeutic Antibody Candidates

Alison Turner, Group Leader, Biophysics, Biology, UCB Celltech

Characterization of Acidic Species in Monoclonal Antibody

Li Zang, Ph.D., Senior Scientist, Analytical Development, Biogen

Late-Stage Characterization of a Therapeutic Enzyme

Peter Bernhardt, Ph.D., Senior Scientist, Analytical Development, Shire

Exploring the Generation of Variants in QbD

James Sutter, MSc, MBA, Associate Manager, Biotech Process Sciences, Down Stream Process, Merck Serono


HIGH THROUGHPUT CHARACTERIZATION TESTING AND BIOASSAY DEVELOPMENT

High Throughput Label-Free Characterization of mAb Binding Kinetics

Vishal Kamat, Ph.D., Scientist, Therapeutic Proteins, Regeneron Pharmaceuticals

Bioassays to Quantify a Therapeutic Fc-Fusion Protein in Pre-Clinical Studies

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


POST-TRANSLATIONAL MODIFICATIONS

Multi-Angle Effector Function Analysis of Human Monoclonal IgG Glycovariants

Tilman Schlothauer, Ph.D., Senior Scientist, Biochemical and Analytical Research, Large Molecule Research; Roche Pharma Research and Early Development (pRED), Roche Innovation Center Penzberg


CHARACTERIZATION OF COMPLEX MOLECULES AND NOVEL FORMATS

Method For Postsynthetic Characterization of Multi Antibody Polymalic Acid Conjugates

Eggehard Holler, Ph.D., Professor & Research Scientist III, Neurosurgery, Cedars-Sinai Medical Center

Analytical Methods to Characterize Bispecifics

Samadhi Vitharana, Ph.D., Principal Scientist, Core Sciences & Technology, Takeda California


Understanding Size Dependance of Rabbit Vitreal Clearance 

Whitney Shatz, Ph.D., Senior Research Associate, Genentech, Inc.           

 

 


For more details on the conference, please contact: 

Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute
Tel: +1 816 472 0701
Email: mlangley@healthtech.com 

For partnering and sponsorship information, please contact: 

Carol Dinerstein,
Director, Business Development
Cambridge Healthtech Institute
Tel: 1 781-972-5471
Email: dinerstein@healthtech.com 

Jason Gerardi
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5452
Email: jgerardi@healthtech.com