ANALYTICAL STREAM  

2nd Annual  

Biophysical & Biochemical Characterization of Biotherapeutics April 30 - May 1

Many recent pharmaceutical advances are based on detailed knowledge and characterization of the underlying proteins involved. Many companies are working to meet those demands through new tools, technologies, and assays. More important than the tools themselves is the hard work of applying the technologies appropriately to each situation and evolving a true analytical strategy.

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SUNDAY, APRIL 29

2:00-5:00 pm Recommended Short Course*

• SC11 - Molecular Imaging on Tissues Using Mass Spec 

*Separate registration required.

4:00 - 6:00 pm Main Conference Registration

MONDAY, APRIL 30

7:00 am Registration and Morning Coffee

PROTEIN PROFILING AND ITS ROLE IN TARGET IDENTIFICATION AND DRUG DEVELOPMENT 

8:30 Chairperson’s Opening Remarks

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

Jennifer Nemeth, Ph.D., Principal Research Scientist, Biologics Mass Spectrometry & Allied Technologies, Janssen R&D

8:40 Tissue Imaging and its Applicability in the Development of Therapeutics

Jennifer Nemeth, Ph.D., Principal Research Scientist, Biologics Mass Spectrometry & Allied Technologies, Janssen R&D (biography)

The direct imaging for tissues using MALDI-TOF MS has been an emerging field over the past twelve years. This technology has opened up the possibility of tracking drugs and/or drug metabolites, within tissues for the purpose of localization and PK studies. Presented will be a historical perspective on the field and highlight possibilities for drug discovery.

9:10 Imaging Drug Distribution with Mass Spectrometry

Stacey Oppenheimer, Ph.D., Principal Scientist, World Wide Medicinal Chemistry, Pfizer (biography)

Mass spectrometry imaging is a useful tool for drug discovery studies due to its ability to elucidate the spatial distribution of non-labeled therapeutics. This technology offers a unique compliment to conventional LC-MS analysis of drugs in tissues, which requires sample homogenization, because it maintains the spatial localization of drugs and their metabolites and enables correlation with histochemistry techniques. This talk will highlight some impacts mass spectrometry imaging has had in pharmaceutical research ranging from oncology and neuroscience to environmental safety.

9:40 Towards Implementation of MALDI IMS into the Drug Development Workflow: Bridging Histology and Drug Tissue Distributions

Reid Groseclose, Ph.D., Investigator, DMPK, GlaxoSmithKline (biography)

We will present data that demonstrates the ability of IMA to link chemistry and biology and provide examples of how this is permitting us to examine the basis of drug toxicity and pharmacology and refine our understanding of pharmacokinetics and drug transport. Examples will include distribution analysis of a drug and its metabolites in liver tissue and the correlation with observed hepatotoxicity, assessment PK/PD relationship for a drug and key metabolites in tissues, and comparative CNS penetration and metabolism of a compound and its metabolites in different pre-clinical models.

10:10 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

11:10 Use of Proteomics in Advancing Drug Discovery Programs

Steve Pomerantz, Senior Research Scientist, Biologics Mass Spectrometry & Allied Technologies, Janssen R&D (biography)

Mass spectrometry-based proteomics has tremendous potential to impact the entire product life cycle through commercial release. Pertinent proteomic techniques, interspersed with case histories, to support target discovery and target validation studies will be presented. Particular emphasis will be placed on the utility of multiple reaction monitoring (MRM) assays to drive drug development.

11:40 Successful Mass Spectrometry Strategies for Biomarker and Target Discovery and Verification

Daniel Chelsky, Ph.D., Chief Scientific Officer, Caprion (biography)

Two mass spectrometry methods have been applied for the rapid discovery of biomarker and target candidates. A non-hypothesis driven strategy is used to identify and compare proteins in samples from multiple cohorts when no candidates exist. Alternatively, an MRM assay can compare hundreds of specific proteins with known biological associations. Successful examples of both approaches will be presented.

Sponsored by
12:10 pm Antibody Screening and Characterization Using Multiplexed SPR

Ruben Luo, Ph.D., Product Manager, Bio-Rad Laboratories

Measure 36 label free interactions simultaneously and with greater experimental design flexibility utilizing the 6 x 6 fluidics array of the ProteOn XPR 36 biosensor. Antibody characterization and epitope binning are completed in a fraction of the time as compared to serial flow biosensors.

12:25 Sponsored Presentation (Opportunity Available)

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

ANALYTICAL CHARACTERIZATION
OF BIOPHARMACEUTICALS 

2:00 Chairperson’s Remarks

Steven Berkowitz, Ph.D., Principal Investigator, Analytical Development, Biogen Idec, Inc.

2:35 Rapid Profiling of N-linked Glycans from Monoclonal Antibodies Using Microfluidic-Based Chip NanoLC-MS

Niclas Tan, Ph.D., Scientist, Analytical Development, Biologics, Millennium: The Takeda Oncology Co. (biography)

Characterization of glycan post-translational modifications of therapeutic antibodies is of utmost importance due to their impact on efficacy, half-life, stability and mechanism of action. Traditional assays involving fluorophore-labeled glycans are tedious and typically require days to complete. Here we present a novel integrated microfluidic-based LC-MS chip for rapid online cleavage, purification, separation, identification and quantitation of label-free N-linked glycans from monoclonal antibodies based on accurate mass.

3:05 Improved Quantitation of Glycans Released from Biotherapeutics

Ron Orlando, Ph.D., Professor, Biochemistry and Molecular Biology, Complex Carbohydrate Research Center, University of Georgia (biography)

Glycosylation is one of the most common post-translational modifications encountered in eukaryotic systems. One of the analytical challenges facing scientists in the characterization of glycoproteins involves the ability to identify and quantify changes in the attached glycans. This topic is of importance to a variety of researchers that ranges from those involved in the batch to batch analysis of recombinant glycoproteins to those involved in glycomics.

3:35 Physico-Chemical Methods to Assure Higher Order Structure in Biosimilars

Mary Alice Hefford, Ph.D., Senior Research Scientist, Biologics and Genetic Therapies Directorate, Health Canada (biography)

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

5:45-6:45 Welcome Reception in the Exhibit Hall with Poster Viewing

Day 1 | Day 2 | Download Brochure