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«  USP WORKSHOP ON GLYCOSYLATION ANALYSIS FOR BIOPHARMACEUTICALS August 25-26, 2015 USP Meetings Center, Rockville, MD USA Final Agenda DAY ONE: ...»

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USP WORKSHOP ON GLYCOSYLATION ANALYSIS

FOR BIOPHARMACEUTICALS

August 25-26, 2015

USP Meetings Center, Rockville, MD USA

Final Agenda

DAY ONE: Tuesday, August 25, 2015

8:00 – 8:30 a.m. Registration

8:30 – 8:40 a.m. USP Welcome & Workshop Introduction

 Tina Morris

Senior VP, Science Global Biologics, USP

SESSION 1

Opening Keynote Presentation

Introduction: Chris Jones, Ph.D.

8:40 – 9:20 a.m. The Critical Features of Glycosylation for the Therapeutic Products  Pauline M. Rudd, Ph.D.

National Institute for BioProcessing Research and Training in Ireland (NIBRT), University College, Dublin (Ireland) SESSION 2 The Role of Glycosylation for Therapeutic Proteins Moderator: Michael DeFelippis, Ph.D.

9:20 – 9:45 a.m. The Use of Alternative Methods as Surrogate Measures of Biological Activity  Guoying Jiang, Ph.D.

Genentech 9:45 – 10:10 a.m. Break 10:10 – 10:35 a.m. Characterization and Impact of Glycosylation in an IgG fusion protein  Christopher Barton, Ph.D.

MedImmune 10:35 – 11:00 a.m. Case Study: Influence of Fab Glycosylation on The Pharmacological Properties of a Monoclonal Antibody  Bryan Harmon, Ph.D.

Eli Lilly and Company   USP Workshop on Glycosylation Analysis for Biopharmaceuticals Workshop August 25-26, 2015  USP Meetings Center, Rockville, Maryland USA   11:00 a.m. – 11:30 a.m. Panel Discussion 11:30 a.m. – 12:30 p.m. Lunch & Poster Session SESSION 3 Current Technologies Moderator: Trish Li, Ph.D.

12:30 – 12:55 p.m. Common Analytical Methods for Oligosaccharide and Monosaccharide Analysis  Parastoo Azadi, Ph.D.

Member, USP Glycoproteins and Glycan Analysis Expert Panel 12:55 – 1:20 p.m. The Common Challenges Faced Today When Performing

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USP Workshop on Glycosylation Analysis for Biopharmaceuticals Workshop August 25-26, 2015  USP Meetings Center, Rockville, Maryland USA

USP WORKSHOP ON GLYCOSYLATION ANALYSIS

FOR BIOPHARMACEUTICALS

Speaker / Moderator / Planning Committee Information (alpha order) Parastoo Azadi, Ph.D.

USP Affiliation:

Member, USP Glycoproteins and Glycan Analysis Expert Panel Technical Director University of Georgia Athens, GA, USA Dr. Azadi received her B.Sc. in Chemistry in 1987 from University of North London, UK and her Ph.D. degree in biochemistry in 1991 from Imperial College of Science and Technology, University of London, studying structural characterization of carbohydrates and glycoproteins by mass spectrometry under the supervision of Profs. A. Dell and H.R. Morris.

In 1990 through to 1994 she was the senior scientist and the study director at M‐ Scan limited, an Analytical Mass Spectrometry Consultancy in UK where she was responsible for complete structural characterization of native and recombinant proteins and glycoproteins using mass spectrometry as a service to the pharmaceutical industry.

In 1994 she joined the Complex Carbohydrate Research Center as a postdoctoral fellow and studied the effect of the enzymes endohyrolase and endolyase on rhamnogalacturonan I, and characterization of the fragments produced by these enzymes by ESI‐MS and ESIMS/MS. In 1996 she became the Associate Technical Director of plant and microbial Analytical Services at the Complex Carbohydrate Research Center where she was responsible for plant and microbial service program where polysaccharides and lipopolysaccharides were analyzed for other institutes.

Since 2001, Dr. Azadi has been the Technical Director of Analytical Service and Training at the Complex Carbohydrate Research Center. As the Technical Director, the she oversees and manages all analytical services and training conducted at the CCRC, which are supported by three federal resource centers of excellence that CCRC has been awarded: The Department of Energy‐funded Center for Plant and Microbial Complex Carbohydrates, the National Institutes of Health Resources Center for Integrated Glycotechnology, and the National Institutes of Health for Biomedical Glycomics. The analytical service program offers two main areas of service: standard analyses and contract analyses. The samples submitted for these types of analyses come from academic, government, non‐profit organizations and private companies, throughout the United States and internationally.

Dr. Azadi works closely with the research scientists in industry on developing carbohydrate based drugs and the need for out‐sourcing prior to phase I and phase II clinical trials.

U.S. PHARMACOPEIAL CONVENTION

Her laboratory also conducts research in areas of structural characterization of plant, bacterial and animal polysaccharides, glycoproteins and glycolipids using MS and NMR techniques.

Planning Committee Member Moderator Session 6: Emerging Technologies Wednesday, August 26, 2015, 9:10 a.m. – 11:45 a.m.

Presentation Abstract Common Analytical Methods for Oligosaccharide and Monosaccharide Analysis Tuesday, August 25, 2015, 12:30 p.m. – 12:55 p.m.

Production of high‐quality pharmaceutical recombinant therapeutic glycoprotein with consistency in glycan quality is still challenging. Since glycans are responsible for bioactivity, solubility, immunogenicity, and clearance rate from circulation, it is vital to have detailed map of glycans in recombinant therapeutic glycoprotein.





However, due to the enormous diversity of carbohydrate structures and their heterogeneity, this still remains one of the bottlenecks of full structural characterization. Detailed glycoprotein structural analysis has to be able to identify the peptide sequence where the glycans are attached, as well as the structure of the glycan portion, including oligosaccharide sequence and glycosyl linkages. We will detail methods for mass spectrometry (MS) experiments on both released glycans (“glycomics”), as well as on intact glycopeptides (“glycoproteomics”) using EDT, HCD and CID fragmentation pathways that are needed to fully elucidate the structure of glycoproteins. Additional protocols will be shown where a combination of glycosyl composition and glycosyl linkage analysis using a combination of methylation analysis, MSn and exoglycosidase digestion will provide information on the glycan topology as well as detection methods for potential non‐human modifications that could arise from mammalian expression systems such as Galα1‐3Gal and N‐glycolylneuraminic acid (NeuGc). Our consolidated experiments will outline all the necessary information pertaining to the glycoprotein, including glycan fine structure, attachment site, and glycosylation degree to be obtained pharmaceutical recombinant glycoproteins.

USP Workshop on Glycosylation Analysis for Biopharmaceuticals Workshop August 25‐26, 2015, USP Meetings Center, Rockville, Maryland, USA Christopher Barton, Ph.D.

Senior Scientist MedImmune Washington, DC, USA Chris is a Senior Scientist at MedImmune, leading the novel molecules group within analytical biotechnology. He started working on carbohydrate analytics during a PhD on polysaccharides and glycoprotein synthesis at the University of Cambridge. He completed post‐doctoral training working in a UK anti‐doping laboratory, and developed expertise in mass spectrometry in the contract research sector. His role at MedImmune is focused on the development of analytical approaches for the testing and characterization of non‐monoclonal antibody products. His research interests include developing tools for the analysis and understanding of protein glycosylation and post‐translational modification in cell culture.

Presentation Abstract Case Study: Characterization and Impact of Glycosylation on PK of an IgG fusion protein Tuesday, August 25, 2015, 10:10 a.m. – 10:35 a.m.

Non‐monocloncal antibody biotherapeutics often have multiple glycosylation sites occupied with a range of galactosylated and sialylated glycans. The nature and extent of these species can impact the protein’s pharmacokinetic and pharmacodynamic profile, and is an important feature to monitor during biotherapeutic development.

We present a case study of the characterization of N‐glycosylation in a dimeric IgG fusion protein with two Fc glycosylation sites and four non‐Fc sites. The glycosylation of the protein was characterized by a series of tools of increasing detail. The first stage was compositional analysis of the level of component neutral monosaccharides and sialic acid species. Oligosaccharide profiling of enzymatically released glycans was then undertaken to characterize the global glycosylation profile of the protein. Finally analysis by peptide mapping was used to determine the site‐specific glycosylation pattern.

The model protein was determined to be decorated with distinct glycans at each of the N‐glycosylation sites. The Fc was occupied primarily by agalactosylated bi‐ antennary glycans. The non‐Fc glycans were occupied by a broader range of species, with bi‐antennary and tri‐antennary cores being observed, decorated with variable levels of galactosylation and sialylation.

We further present an approach to understand the impact of glycosylation on protein function at an early stage in development, by producing samples of protein with specific glycosylation patterns and studying these in in vitro and in vivo model systems, including a non‐human primate model to study the impact of

–  –  –

glycosylation on PK. This information can be combined with the glycosylation analysis tools described above to target process development on a protein with the most desirable glycosylation state.

–  –  –

Edith Chang, Ph.D.

Scientific Liaison, Global Biologics U.S. Pharmacopeia (USP) Rockville, MD, USA Dr. Chang is a Scientific Liaison of Global Biologics with USP. She serves as a lead liaison for USP Proteins Expert Committee. Dr. Chang received her M.S. and Ph.D. in Biochemistry with a minor in Molecular Genetics from University of California, Riverside. Prior to joining USP, she worked most recently at Kansas City University of Medicine and Biosciences, Kansas City, MO, where she was Assistant Professor of Biochemistry and Principle Investigator for research projects to investigate the role of cyclooxygenase 2 in malignant transformation and cancer invasion. Earlier employment was at Thermo Fisher Pierce where she was a Research Scientist at R & D department.

Dr. Chang is the author or co‐author of many peer‐reviewed publications in the fields of biochemistry, molecular biology and cancer, and has served as an ad‐hock reviewer for several peer‐reviewed journals including Cancer Research, Molecular Cancer Therapeutics, Clinical Cancer Research, and The International Journal of Biochemistry & Cell Biology.

Planning Committee Member Presentation Abstract USP Reference Standards Tuesday, August 25, 2015, 2:55 p.m. – 3:05 p.m.

USP Reference Standards (RSs) are highly-characterized physical specimens used in testing by pharmaceutical and related industries, and are closely tied with the documentary standards published in the USP–NF, Food Chemicals Codex, and Dietary Supplements Compendium. This presentation will provide an overview of USP reference standards, and discuss the biologics RSs that are associated with compendial procedures for analysis of protein glycosylation.

–  –  –

John Cipollo, Ph.D.

USP Affiliation:

Government Liaison, Vaccines for Human Use – Viral Vaccines Senior Staff Fellow U.S. Food and Drug Administration Bethesda, MD, USA Dr. Cipollo received his Ph. D. in 2000 from the State University of New York at Albany. He performed his post‐doctoral work at Boston University School of Dental Medicine under Professors Catherine Costello in mass spectrometry and Carlos Hirschberg in biochemistry. He has published over thirty scientific articles in the areas of carbohydrate structural analysis and glycomics with strong emphasis in carbohydrate mass spectrometry. Dr. Cipollo has worked extensively in the glycomics of a series of organisms including human, Caenorhabditis elegans, Entamoeba invadens, Entamoeba histolytica, and several yeast species. His current interests include the function of glycosylation in protein carbohydrate interactions in adaptive and innate immunity and the impact of those functions in vaccine development and performance. Other interests include novel chemistries for improvement of polysaccharide conjugate and other glycoconjugate based vaccines. As there are few broadly accepted informatics platforms for glycomics analysis the Cipollo group has, and is currently developing, in house glycomics software for processing of mass spectrometry and glycan array glycomics data Dr.

Cipollo serves as a Product Specialist for CBER FDA primarily as a product reviewer for bacterial polysaccharides and polysaccharide conjugate vaccines.

Planning Committee Member Moderator Session 7: Regulatory Approaches on Glycosylation Wednesday, August 26, 2015, 12:45 p.m. – 2:00 p.m.

USP Workshop on Glycosylation Analysis for Biopharmaceuticals Workshop August 25‐26, 2015, USP Meetings Center, Rockville, Maryland, USA Tapan Das, Ph.D.

Director, Biologics Development Bristol‐Myers Squibb New York, USA Tapan is a Director in the Analytical Development group of Bristol‐Myers Squibb.

He leads the Mass Spectrometry and Biophysics Center of Excellence engaged in advanced characterization and analytics for biologics development.

Prior to joining BMS, he was at Pfizer Biotherapeutics R&D and built a world class state‐of‐the‐art facility for Biophysical Center of Excellence.

Tapan is a member of AAPS (Amercian Association of Pharmaceutical Scientists) and served AAPS in various roles, most recently served as the Chair of the Biotechnology Section.

Presentation Abstract Practical Glycoprofiling Approach for Measurement and Control of Glycosylation) Tuesday, August 25, 2015, 1:20 p.m. – 1:45 p.m.

Glycan composition is a key quality attribute for many protein therapeutics.



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