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Analytical Methods & Technologies

Analytical Methods & Technologies

Analytical Methods & Technologies

Monday, March 30, 2015 - Thursday, April 2, 2015

A must-attend track for scientists seeking novel analytical methods for accurate characterization of biologics. From comparability and characterization strategies to QbD concepts to aggregation and subvisible particle analysis, get the tools and applicable knowledge you need to enhance your operation's process and product quality.

» Download Agenda | Register Now

Session Highlights

  • Keynote or Featured Presentation
  • Case Study
  • New Data
  • Panel Discussion

Analytical Methods & Technologies

Monday, March 30, 2015

7:00
Registration and Coffee

Keynote Presentations

8:00
Chairperson's Opening Remarks
Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, Biotechnologies R&D, GE Healthcare Life Sciences, Sweden

8:15
James Swartz, Ph.D. Engineering Novel Proteins and Protein Assemblies as Innovative Therapeutics, Vaccines, and DrugDelivery Vehicles
James R. Swartz, Ph.D., James H. Clark Professor, School of Engineering, and Professor of Chemical Engineering and of Bioengineering, Stanford University

9:00
Dana Andersen, Ph.D. Challenges and Opportunities in Pharmaceutical Development
Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech - a Member of the Roche Group

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:25
Chairperson's Remarks
Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia

Formulation & Delivery Developments

10:30
Developing Drug/Device Combination Products for Oral Inhalation
Developing drug/device combination products requires early integration of formulation and device technologies. For inhalation products, dry powder formulations and inhalation devices are intrinsically linked and product development challenges can be simplified when these efforts are combined at an early stage. This presentation will address these challenges with case studies of inhaled drug/device combinations products.
Andrea Leone-Bay, Vice President, Pharmaceutical R&D, MannKind

Comparability Strategies for Biosimilars and Other Biotechnology Products

11:00
Building Mass Spectral Libraries for the NISTmAb Reference Material
M. Lorna De Leoz, Ph.D., NIST Mass Spectrometry Data Center, National Institute of Standards and Technology

11:30
Case Studies on Comparability Assessment of Biological Drug Products
Overview of Drug Product changes that necessitate demonstration of comparability and general approaches for appropriate comparison of Drug Product quality attributes of the pre-change to post-change will be discussed. Accelerated and stress stability studies are often useful tools for comparison of degradation rates and degradation profiles of pre-change to post-change Drug Products. However, stress comparability assessment of biological Drug Products has its own challenges. Case studies on stress comparability assessment of biological Drug Products during manufacturing site transfers and process changes will be presented.
Camellia Zamiri, Ph.D., Scientist, Genentech, a Member of the Roche Group

12:05
Technology Workshop presentation available

12:35
Networking Luncheon in Poster and Exhibit Hall

1:40
Chairperson's Remarks
John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, NIST

Comparability Strategies for Biosimilars and Other Biotechnology Products (continued)

1:45
Tina Morris The Role of Pharmacopeial Standards in the Context of Biosimilars
Tina Morris, Vice President, Biologics & Biotechnology, United States Pharmacopeia

2:15
Application of NMR Spectral Fingerprinting for Structure Assessment of Monoclonal Antibody Therapeutics
High-resolution NMR methods can provide spectral 'fingerprints' of the higher order structure of protein therapeutics at atomic resolution. This presentation will report on the application of NMR methods for obtaining NMR 'fingerprints' of monoclonal antibody therapeutics and how these spectral 'fingerprints' can be used to establish consistency in drug manufacturing and for comparing a biosimilar to an innovator reference product.
John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group, NIST

2:45
Success and Lessons Learned in Characterization and Comparability
Moderator: Parastoo Azadi, Ph.D., University of Georgia
Panelists:
M. Lorna De Leoz, Ph.D., National Institute of Standards and Technology
Camellia Zamiri, Ph.D., Genentech, a Member of the Roche Group
John P. Marino, Ph.D., NIST
Tina Morris, United States Pharmacopeia

3:15
Networking Refreshment Break in Poster and Exhibit Hall

Development of Biosimilars - Considerations during Cell Culture

4:00
The Production of Antibodies as Single Glycoforms or with a Restricted Glycosylation Profile
Michael Butler, Ph.D., Professor of Microbiology, University of Manitoba, Canada

4:30
Challenges in Comparability Studies of Carbohydrate Containing Biosimilars
Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia

5:00
Presentation TBA

5:30
Welcome to the BDP Big Top!
Grab your popcorn and peanuts as you make your way through the exhibit hall for your front row look at the most amazing display of biopharmaceutical technologies and services all under the BDP Big Top!

Tuesday, March 31, 2015

7:30
Registration and Coffee

8:00
Chairperson's Remarks
Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Analytical Characterization for ADCs

8:15
Yan Chen, Ph.D. Overcoming Analytical Challenges during Development and Production of ADCs
Overview of Drug Product changes that necessitate demonstration of comparability and general approaches for appropriate comparison of Drug Product quality attributes of the pre-change to post-change will be discussed. Accelerated and stress stability studies are often useful tools for comparison of degradation rates and degradation profiles of pre-change to post-change Drug Products. However, stress comparability assessment of biological Drug Products has its own challenges. Case studies on stress comparability assessment of biological Drug Products during manufacturing site transfers and process changes will be presented.
Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc.

8:45
Real-Time Monitoring of ADC Conjugation Process
Antibody Drug Conjugates have process development and manufacturing challenges in part due to the uniqueness of combining a tumor targeting antibody with a potent small molecule cytotoxic agent. This presentation shows the application of real time monitoring of ADC conjugation reactions to process development and potential usefulness of real time monitoring during scale up and manufacture.
Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas

9:15
Analytical Development and Characterization Tools(3-D Structure of mAb/ADCs, Mass Spec)
Oscar Salas-Solano, Ph.D., Senior Director of Analytical Sciences, Seattle Genetics, Inc.

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:25
Chairperson's Remarks
Thomas A. Little, Ph.D., President, Thomas A. Little Consulting

QbD/CQA Concepts from Development to Submission

10:30
Essentials in Quality by Design for Modern Biologics Development
QbD is a systematic approach to development that begins with predefined development objectives and emphasizes product and process understanding and process control, based on sound science, data based decision making and quality risk management. Quality by Design as introduced by the FDA and EU brings modern drug development methodologies to CMC teams working on biologics, pharmaceuticals and vaccines. The presentation will discuss the application of QbD principles in the development, submission and manufacturing of drug product and drug substance. Most CMC development teams globally have little to no experience in generation of design space, selection of PAR/NOR ranges and preparing for Stage I Validation documentation and submission. This presentation will cover basic and advanced principles for the practical application of QbD in every phase of product development and control.
Thomas A. Little, Ph.D., President, Thomas A. Little Consulting

11:00
The Role and Design of Forced Degradation Studies in Biologics Development
Xiaoyu Chen, Section Leader, Late Stage Analytics, Merck

11:30
Successfully Applying QbD Concepts to Develop a Robust Lyophilized Protein Therapeutic Product
This case study demonstrates how to apply Quality-by-Design (QbD) concepts to develop a robust lyophilized dosage form for an inherently unstable protein therapeutic. The presentation will walk through design and execution processes: risk assessment, analytical method readiness, multivariate statistical design, acquisition of representative data, and data crunching in order to propose a sound product formulation in the context of designated container closure systems.
Kevin Zen Ph.D., Senior Manager, Biologics Development, Allergan

Technology Workshop Presentation

12:05
Single-use Fermentation: Understanding Process Economy and Process Performance
Ken Clapp, Product Manager, Bioreactors, GE Healthcare

12:35
Networking Luncheon in Poster and Exhibit Hall

1:40
Chairperson's Remarks
Mark Emanuele, Process Engineer, Genzyme

Aggregation and Subvisible Particle Analysis in Protein Drug Products

1:45
Resolution of Heterogeneous Charged Antibody Aggregates via Multimodal Chromatography:Comparison to Conventional Approaches
Clearance of aggregates during protein purification is increasingly paramount as protein aggregates represent one of the major impurities in biopharmaceutical products. Aggregates, especially dimer species, represent a significant challenge for purification processing since aggregate separation coupled with high purity protein recovery can be difficult to accomplish. Biochemical characterization of the aggregate species from the hydrophobic interaction and cation exchange chromatography elution peaks revealed two different charged populations, i.e. heterogeneous charged aggregates, which led to further challenges for chromatographic removal. This paper compares multimodal versus conventional cation exchange or hydrophobic chromatography methodologies to remove heterogeneous aggregates. A full, mixed level factorial design of experiment strategy together with high throughput experimentation was employed to rapidly evaluate chromatographic parameters such as pH, conductivity, and loading. A variety of operating conditions were identified for the multimodal chromatography step, which lead to effective removal of two different charged populations of aggregate species. This multimodal chromatography step was incorporated into a monoclonal antibody purification process and successfully implemented at commercial manufacturing scale.
Rebecca A. Chmielowski, MSD, Biologics Process Development, Process Development and Engineering, Merck

2:15
Analyzing Subvisible Particles in Protein Drug Products: A Comparison of Dynamic Light Scattering (DLS) and Resonant Mass Measurement (RMM)
Aggregation is common in protein drug manufacture, and while the effects of protein particulates are under investigation, many techniques applicable for their characterization have been recently developed. Among the methods available to characterize and quantify protein aggregates, none is applicable over the full size range and different methods often give conflicting results. The studies presented here compare two such methods: dynamic light scattering (DLS) and resonant mass measurement (RMM). The performance of each method was first characterized using polystyrene particle size standards (20, 60, 100, 200, 400, and 1,000 nm) over a range of concentrations. Standard particles were measured both singly and in binary mixtures containing 20 nm particles at a fixed concentration (10(14) particles/mL) and various concentrations of one of the other particle sizes (i.e., 60, 100, 200, 400, or 1,000 nm). DLS and RMM were then used to detect unknown aggregate content in stressed samples of IgG. Both instruments were shown to have a working range that depends on particle size and concentration. In binary mixtures and polydisperse solutions, DLS was able to resolve two species in a manner dependent on both concentration and particle size. RMM was able to resolve particles above 200 nm (150 nm for protein) at concentrations below 10(9) particles/mL. In addition, dilution was evaluated as a technique to confirm and quantify the number of particles in solution.
Jainik Piyushkumar Panchal, Post Doctoral Fellow, Purdue University

2:45
Networking Refreshment Break in Poster and Exhibit Hall

Analytical Characterization Methods for Critical Quality Attributes

3:30
Characterization of Potential Degradants in a 20 kDa PEGylating Raw Material by Orthogonal Analytical Techniques (RP-HPLC, APCI-MS and NMR)
Ying Luo, Process and Product Development, Amgen, Inc.

4:00
Process Characterization of Vaccine Candidates: Where Do We Start?
When we speak of process characterization, we often think of a process in their late phase of clinical manufacture and qualification. Usually, there is a desire to characterize "everything" without really going a systemic methodology of performing characterization. In this talk, we will be looking at some of the ICH guidelines and how we use those guidelines to appropriately stage process characterization. The discussion would cover examples of process characterizing microbial expressed vaccine antigens. The process starts with performing a process risk assessment, performing small-scale model, characterizing unit operations to obtain operating parameters to control your process to meet critical quality attributes.
Eric Chojnicki, Ph.D., Director CMC, Biologics Development, Allergan

4:30
Platform for Media and Bioreactor Nutrient Analysis
A platform for media nutrient characterization was established at the contract research organizations (CROs) and Allston MSAT Laboratory. Analytical methods of Ultra Pressure Liquid Chromatography Triple Quadrapole Mass Spectrometry (UPLC/MS/MS) and Inductively Coupled Plasma Mass Spectrometry (ICP/MS), as well as Blood Gas Analyzer (BGA), were used to analyze formulated media and bioreactor retains for amino acids, vitamins, trace elements and sugars. Cell culture media samples (pre- and Post a 0.1 µm filter) were collected over a six-month period and analyzed to determine if the nutrient concentrations were consistent and if they were in agreement with theoretical target values. In addition, a comparison between pre- and post-filter samples was performed to identify if nutrient loss was occurring during the filtration process. Perfusion bioreactor samples (spent media) were collected from the growth, transition and harvest phases to understand the nutrient profiles. The study results show the formulated media is consistently prepared and is at the theoretical concentrations, with the exception of two components. The study results also showed loss after filtration for one component. The bioreactor nutrient profiles show a decrease or depletion of several nutrients, while an increase of other nutrients were observed.
Mark Emanuele, Process Engineer, Genzyme

5:00
Close of Day Two

5:30
BDP Week Beach Party
Back by Popular Demand!
Shimmering views of the Pacific Ocean will be the back drop at this fun, casual networking reception. You'll enjoy beach-themed food, drink and music in this unparalleled coastal setting as you network with speakers, attendees and exhibitors. Free for All Registered Attendees - RSVP required.

Session Highlights

  • Keynote or Featured Presentation
  • Case Study
  • New Data
  • Panel Discussion

Analytical Methods & Technologies

Wednesday, April 1, 2015

7:30
Registration and Coffee

Keynote Presentations

8:00
Chairperson's Remarks
Uwe Gottschalk, Ph.D., Chief Technology Officer, Pharma Biotech, Lonza, Switzerland

8:15
Tae Han Kim Manufacturing in a Global Market Place
Tae Han Kim, Ph.D., President and CEO, Samsung BioLogics

8:45
Hitto Kaufmann, Ph.D. Innovation in Biologics Manufacturing
Hitto Kaufmann, Ph.D., Vice President, Technology and Innovation, Sanofi Biologics, Germany

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:25
Chairperson's Remarks
Edward Koepf, Ph.D., Process Development Scientist, Biogen Idec

Quantitation and Control Strategies for HCPs

10:30
Antigen Excess and Avoiding HCP Quantitation Errors
Immunoassays are typically used to monitor residual host cell protein (HCP) clearance from biopharmaceuticals. Antibodies to a complex mixture of total HCPs are generated for this purpose. One quantification error potentially occurs if a particular protein co-purifies with product and is present in excess of the available anti-HCP antibodies in the assay ("antigen excess"). We have explored different assay formats to monitor and address the antigen excess phenomenon.
Sara Parker, Ph.D., Senior Manager Analytical Operations, Genentech, a Member of the Roche Group, Inc.

11:00
Analytical Challenges and Solutions for In-House HCPs Assay Development, Case Studies from HCPs Antigen Selection to Anti-HCPs Reagents Qualification
ELISA is the most commonly used method for monitoring HCPs clearance during biologics production. The performance of HCP ELISA is highly relied on the anti-HCPs reagents used. This talk will cover the major analytical challenges occurred during in-house HCP assay development, from antigen selection to antibody qualification, with the focus on finding the scientific solutions to overcome these challenges.
Fengqiang Wang, Ph.D., Principal Scientist, Sterile Product and Analytical Development, Merck

11:30
Comparing a New Methacrylate Protein A Resin with Agarose Protein A-Focus on Host Cell Protein Clearance
A case study is presented whereby one of the newly developed macroporous polymethacrylate Protein A resins, Amsphere Protein A, was evaluated for binding capacity, pressure-flow characteristics, alkaline stability, and impurity clearance capabilities. As part of impurity clearance several unique wash solutions were evaluated for their ability to further improve host cell protein reduction. Results are compared to agarose Protein A.
Edward Koepf, Ph.D., Process Development Scientist, Biogen Idec

Concurrent Technology Workshop Presentations

12:05
Downstream Processing and New Technology for Continuous Chromatography
Maria Ekblom, Senior Project Manager, Chromatography Systems, GE Healthcare

Capture Chromatography: Alternativesfor Downstream Process Development
Shelly Parra, M.S., Sr. Field Application Scientist, Thermo Fisher Scientific

12:35
Networking Luncheon in Poster and Exhibit Hall

1:40
Chairperson's Remarks
Vladamir Razinkov, Principal Scientist, Process & Product Development, Amgen, Inc.

Quantitation and Control Strategies for HCPs (continued)

1:45
Novel Impurity Challenge Study in mAb AEX Polishing Step
Bo Qi, M.S., Director, Process Development Downstream, Eli Lilly and Company

Chromatography Considerations to Combat HCPs

2:15
Membrane Filtration Can Substitute Chromatography Purification Steps for Plant-Derived and ELP-Tagged Biopharmaceutical Proteins
Chromatographic techniques are most frequently used for the purification of biopharmaceutical proteins. However, identifying an effective capture step can be a challenging task for non-antibody target proteins, especially if these are expressed at low levels or contaminated by a large number of host cell proteins (HCPs) as it is often the case for plant-derived products. In such cases, several HCPs can bind to the capture resin and reduce the effective binding capacity resulting in the necessity for large column dimensions and increasing downstream processing (DSP) costs. A selective removal of HCPs prior to the initial capture step may help to circumvent this problem and reduce costs in DSP. Here we present how membrane based pre-capture purification strategies can simplify DSP and replace chromatographic purification steps for various proteins. On the one hand, we highlight how a design of experiments approach can be used to identify conditions and membrane cut offs for the separation of plant HCPs and target proteins of different molecular masses. On the other hand, we show how membrane inverse transition cycling can be implemented into a scalable production of ELP-tagged target proteins. Both techniques can be easily adapted to other expression systems and thus may be of interested to colleagues from academia as well as from industry. This is especially true for those working with novel non-antibody products of next generation biopharmaceuticals like enzymes and vaccine candidates.
Johannes Felix Buyel, M.Sc., Institute for Molecular Biotechnology, RWTH Aachen University/Integrated Production Platforms, Fraunhofer IME, Germany

High-Throughput Methods and Strategies

2:45
Multidimensional Analysis of mAb Formulations by High Throughput Methods
Vladamir Razinkov, Principal Scientist, Process & Product Development, Amgen, Inc.

3:15
Networking Refreshment Break in Poster and Exhibit Hall

High-Throughput Methods and Strategies (continued)

4:00
High Throughput Determination of IgG Titer in Cell Culture via Affinity Chromatography
In Biotech industry, therapeutic IgGs are mainly produced in two expression systems: Chinese Hamster Ovarian Cell (CHO) and E. coli Cell. In order to determine harvest titer accurately for specific IgG related products, we have developed two rapid affinity chromatography methods targeting different regions on the IgG: 1) 1.5-minute Protein A chromatography method with parallel HPLC setup for IgGs from CHO and 2) 5-minute 2-dimensional Affinity(LC-Kappa®)/Reversed Phase HPLC method for IgG fragments from E. coli. In addition, automation tools used to perform high throughput sample preparation will be discussed in this presentation.
Kevin Lin, Research Associate, Genentech, a Member of the Roche Group

4:30
Assays of Higher Throughput for Efficient Measurement of Drug Potency and Impurity
Assays of higher throughput are needed for meeting the challenge of increasing demand of sample testing during drug development and production. In Biogen we have developed high throughput assays for both potency and impurity measurements. For potency assays, we use "fit-for-purpose" assay formats for testing samples from different stages of product development. For impurity assays, a case study will be presented on the development of a high sensitivity, high throughput assay for quantitation of residual host cell DNA in purification process intermediate and drug substance samples. This new method gives results comparable to our previous method, but significantly lowered the limit of quantitation and increased assay throughput.
Wei Zhang, Ph.D., Principal Scientist, Analytical Development, Biogen Idec

5:00
In-Line Separation by Capillary Electrophoresis Prior to Analysis by Top-Down Mass Spectrometry Enables Sensitive Characterization of Protein Complexes
To analyze intact proteins in the yeast Dam1 complex, we coupled capillary electrophoresis to an Orbitrap Elite mass spectrometer. We achieved a 100-fold increase in sensitivity compared to a RPLC-MS analysis of the Dam1 complex with a total loading of 2.5 ng. N-terminal processing forms of individual subunits were observed as well as their phosphorylation stoichiometry upon Mps1 kinase treatment.
Xuemei Han, Ph.D., Research Associate, The Scripps Research Institute

5:30
International Food Festival
Join us in the exhibit hall as you take a culinary trip around the world, sampling beers paired with foods from countries around the globe, near and far. Sponsored by

Thursday, April 2, 2015

7:30
Registration and Coffee

8:00
Chairperson's Remarks
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a wholly owned subsidiary of Eli Lilly & Co.

Aggregation and Subvisible Particle Characterization and Control

8:15
Characterization of Aggregates in Blood-Derived Products and Their Recombinant Analogs
CDER and CBER recently collaborated to create a new Guidance for Industry document entitled "Analytical Procedures and Methods Validationfor Drugs and Biologics" which is published as a draft in February, 2014. This guidance was designed to update agency thinking on requirements for regulatory submission of analytical procedures and method validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. The draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. The agency also wanted to ensure this draft guidance would complement the International Conference on Harmonization (ICH) guidance documents, especially Q2 (R1) Validation of Analytical Procedures: Text and Methodology (Q2(R1)) for developing and validating analytical methods. In addition to assuring that guidance documents are current, the need for an updated guidance stems from the need to ensure analytical methodologies are consistent with changes to drug development and regulation seen with the concepts outlined in ICH Q8 (R2), Q9, Q10 and Q11.
Lokesh Bhattacharyya, Lab Chief, LACBRP/DBSQC, FDA/CBER/OCBQ (Invited)

8:45
Probing Structurally-Altered and Aggregated States of Therapeutically Relevant Proteins Using GroEL Coupled to Bio-Layer Interferometry
Nature employs chaperone proteins to detect and reverse large scale aggregation in vivo by interacting with partially folded protein species. Using this principle, we developed a GroEL chaperonin-Biolayer Interferometry biosensor to detect initial preaggregates in therapeutic protein formulations prior to large aggregate formation in vitro. We also determine if pre-aggregates detected by the GroEL-biosensor correlates with long term aggregation.
Mark Fisher Ph.D., Professor, Department of Biochemistry and Molecular Biology, Robert E. Hemenway Life Sciences Innovation Center, University of Kansas Medical Center

9:15
Monitoring and Control of Particulates in Protein Therapeutics
Particulates pose major concern in biological therapeutic development because of their potential to cause undesirable immunogenic reactions and other safety concerns. The particulates testing, monitoring, characterization and control strategy will be discussed in this presentation.
Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a wholly owned subsidiary of Eli Lilly & Co.

9:45
Networking Refreshment Break in Poster and Exhibit Hall

Aggregation and Subvisible Particle and Control (continued)

10:30
Late-Breaking Presentation

11:00
Physicochemical Characterization Strategies
Moderator: Arvind Srivastava, Ph.D., Director, Formulation Development, ImClone Systems, a wholly owned subsidiary of Eli Lilly &Co.
Panelists:
Lokesh Bhattacharyya, FDA/ CBER/OCBQ (Invited)
Mark Fisher Ph.D., University of Kansas Medical Center

Technology Workshop Presentation

12:05
Presentation TBA

12:35
Networking Luncheon in Poster and Exhibit Hall

1:40
Chairperson's Remarks
Jeffrey W. Hudgens, Ph.D., Research Chemist, NIST

Operational and Technology Considerations for Product and Process

Featured Presentation

1:45
Don't Go Into the Light! Analytical Characterization of a Photosensitive Therapeutic IgG1 Antibody After Exposure to Light
Galahad Deperalta, Scientist, Protein Analytical Chemistry, Genentech, a Member of the Roche Group, a member of the Roche Group

2:15
Strategies for Increasing Capacity and Capability of an Analytical Organizational Through Improved Technologies and Business Processes
Johnson Varghese, Senior Director, Head of Analytical Development, Shire HGT

2:45
Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing

Methods and Strategies for Glycan Analysis

3:30
Comparison of Glycoproteins by Hydrogen-Deuterium Exchange-Electron Transfer Dissociation-Mass Spectrometry
Hydrogen-deuterium exchange mass spectrometry measures exchange rates of amide hydrogens along protein chains. Since hydrogen bonding associated with the higher order structure of glycoproteins can greatly slow amide hydrogen exchange, small changes in protein tertiary structure can change the H/D exchange profile. We demonstrate that changes in the glycan structure can also measurably change the HDX-MS patterns of glycoproteins.
Jeffrey W. Hudgens, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology Research (CARB II/2204B), BioProcess Measurements Group, Biomolecular Measurement Division, National Institute of Standards and Technology (NIST)

4:00
Comprehensive N-Glycosylation Characterization of Biopharmaceuticals
This presentation will cover the state of the art of liquid phase N-glycan separation methods, mostly focusing on capillary electrophoresis and its combination with mass spectrometry for the analysis of biopharmaceuticals. Comprehensive N-glycosylation analysis of this recently emerging class of very successful new generation drugs will be discussed with the main goal to demonstrate structural and functional equivalence of innovator and biosimilar products.
Andras Guttman, Ph.D., Professor, Horvath Laboratory of Bioseparation Sciences, University of Debrecen, MMKK, Hungary

4:30
Glycan Analysis: An Updated Method for Existing Products
As knowledge about therapeutic recombinant proteins increase, minor glycan species have been identified as critical quality attributes. Newer technologies provide higher resolution and the ability to measure a greater number of glycan species, allowing improved product quality control. In this presentation, considerations for implementing newer analytical technologies for glycan measurement will be discussed.
Deanna Hurum, Ph.D., QC Scientist, Global Method Management and Technology, Genentech, a Member of the Roche Group

5:00
Close of BDP Week

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