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Mastering Immunogenicity 4

September 15-16, 2014

British Consulate-General, Boston MA, USA

Filmed Presentations from all our meetings are available online


Dear Colleague,


This year's Mastering Immunogenicity had the highest content of academic contributions of any meeting in this series. Particularly strong was the focus on mechanisms of immune tolerance and immune regulation. A fundamental tenet that ran through the talks of both Herman Waldmann and Bruce Hall was that antigen-specific tolerance can be induced by a one time signal and be maintained by continuous or at least intermittent antigen encounter. The talks of Georg Lauer and Arlene Sharpe  specifically dealt with immune regulation and molecules in the immune regulatory pathways. These pathways can potentially help to explain immune exhaustion in chronic HCV infection and open significant new avenues in immune oncology. The talk by Nades Palaniya highlighted that our understanding of innate immunity is also continuously evolving, in this case in the area of neutrophil extracellular traps, a unique inflammatory pathway which has only recently been understood in some detail.


Tudor Arvinte's talk focused on the often confounding effects of protein aggregation. Furthermore, the aggregation that occurs in the drug formulation before administration is only part of the story. Aggregation as a consequence of interfacing with blood plasma, blood constituents, such as RBCs and VLDL particles as well as concommittantly administered drugs can in some cases have profound consequences on the how the drug is finally presented to the body.


Day 1: Monday 15th September, 2014


Arrival, registration, breakfast (coffee, tea, pastries)


Welcome and conference overview


Herman Waldmann

Emeritus Professor of Pathology and former Head of the Sir William Dunn School of Pathology at the University of Oxford

Short-term therapeutic intervention  for the therapeutic harnessing tolerance mechanisms.”


Etiena Basner

Children’s Hospital of Philadelphia

“The road to unraveling AAV immunogenicity”


Coffee and Networking


Sabine Zollner

CSL Behring

“Preclinical characteristics of rVIII-SingleChain, a novel recombinant single-chain FVIII under clinical development at CSL Behring”


Takashi Kei Kishimoto

Selecta Bioscience

“Rational design of tolerogenic nanoparticles for the prevention of anti-drug antibodies”




Jeremy Fry

ProImmune Limited

Tools and Technologies for Immunogenicity Risk Management


Georg Lauer

Harvard Medical School

“Chasing the elusive CD4 and CD8 T cell response to HCV infection


Nades Palaniya  

The Hospital for Sick Children, Toronto       

“Targeting innate immune collectins and neutrophil extracellular traps (NETs) to regulate inflammatory diseases”


Coffee and networking


Joleen White

Biogen IDEC

“Evaluation of Peginterferon Beta-1a and Interferon Beta-1a Pharmacokinetics, Pharmacodynamics, and Immunogenicity in Multiple Sclerosis”


Tudor Arvinte    


“Aggregates Phenomena that occur when Therapeutic Protein Solutions Are Mixed With Human Plasma and Human Blood: A New Research and Development Field"


Drinks reception and informal networking for all attendees

Day 2: Tuesday 16th September, 2014




Arlene Sharpe

Harvard University

“T Cell Coinhibitory Pathways and Cancer Immunotherapy: Roles of the PD-1 pathway in controlling tolerance and tumor immunity”


Susan Kirshner


“Therapeutic Proteins: Routes of Exposure and the risk of immunogenicity”


Tim Hickling       


“Contribution of ex vivo assays to immunogenicity risk assessment”


Coffee and Networking


Bruce Hall

University of New South Wales

“Antigen specific CD4+CD25+Foxp3+Treg generated from natural Treg (nTreg)”


Amy Loercher


“ABIRISK Developments and Challenges: Perspectives from Year 2”




Breakout session: Tools and technologies forum (with coffee incorporated)

Moderator:  Bonnie Rup, Pfizer




Conference close



Presentations, Abstracts & Introduction to the Speakers

Prof. Herman Waldmann

Emeritus Professor of Pathology and former Head of the Sir William Dunn School of Pathology at the University of Oxford

Short-term therapeutic intervention for the therapeutic harnessing tolerance mechanisms 

The immune system uses diverse mechanisms of self-regulation to enable it to respond to dangerous pathogens whilst avoiding damage to “self”.  Amongst these, regulatory T-cells are prime players.

These cells can be harnessed therapeutically by giving them, numerical and functional advantages over T-cells that mediate damaging immunity. I will give examples using antibody-based co-receptor and co-stimulation blockade, and also by lymphocyte depletion with antibodies such as CAMPATH-1H, when depletion is followed by “Physician-Guided Reconstitution of the Immune System” (PARIS).

Therapeutic antibodies can themselves be immunogenic, and lessons about mechanisms underlying immunogenicity, have been learned from strategies used to induce tolerance to the CAMPATH-1H antibody.  These will be discussed briefly.


Herman Waldmann, FRS is Emeritus Professor of Pathology and former Head of the Sir William Dunn School of Pathology at the University of Oxford.  An immunologist, he is best known for his work on therapeutic monoclonal antibodies, particularly Campath-1, now licensed as Lemtrada for the treatment of Multiple Sclerosis.

Dr. Waldmann received his undergraduate and graduate degrees from the University of Cambridge and began his scientific career there in the Department of Pathology.  He became Head of the Immunology Division and was named Kay Kendall Chair in Therapeutic Immunology.  It was at Cambridge that he  studied mechanisms by which cells of the immune system could interact to mount immune responses. This early work led him to become interested in immunological tolerance and achieving tolerance for therapeutic purposes.

Since 1980 he has been  funded by an Medical Research Council Programme Grant to study mechanisms of transplantation tolerance and  strategies to achieve this both experimentally and clincially. In 1985 he published the first studies to show that short courses of CD4 antibody therapy could bring about long-term immunological tolerance to foreign proteins, and this work led to the first demonstrations  of  transplantation tolerance resulting from short-tem antibody blockade.

His mechanistic studies of tolerance uncovered a role for regulatory T-cells in infectious tolerance which was published in a seminal paper in Science in 1993. The strategies emerging from his laboratory since that time have been based on the use of therapeutic antibodies to enhance regulation over conventional T-cell immunity.

In order to apply antibodies clinically Waldmann developed the first academic antibody therapeutic manufacturing facility. He and his team were able to apply  clinical-grade antibodies in a wide range of probing therapeutic studies that enabled them to develop a series of humanized antibodies (CD52, CD3, CD4 and others) which have since been transferred to the pharmceutical industry.


His team’s work since 1971 has resulted in more than 500 publications, the majority directed to therapeutic antibodies and their mechanisms of action.  These contributions have led to his election to the Royal Society in 1990. Professor Waldmann is the recipeint of the Jose Carreras Medal of the European Hematology Society,  the Juvenile Diabetes Research Foundation Excellence in Clinical Research Award (2005), Thomas E Starzl Prize in Surgery and Immunology, Scrip Lifetime Achievement award (2007)and an   Honorary Doctorate (DSc) University of Cambridge (2008).




Etiena Basner

Childrens Hospital of Philadelphia


The road to unraveling AAV immunogenicity

Adeno-Associated Virus (AAV) is a non-pathogenic Parvovirus in humans. Due to its properties that it can infect non-dividing cells and that transgenes of interest can be introduced relatively easily it has become a very promising vector for gene transfer.

Using AAV for gene transfer to the liver has been investigated in clinical trials in the past 10 years with increasing success. However humoral and cellular reactions of the immune system to the vector were very soon identified as a major obstacle for successful treatment. Humoral responses presented by neutralizing antibodies to the virus interfere with transduction of target cells while cellular responses by cytotoxic T cells (CTL) eliminate transgene-producing cells thus affecting long term transgene expression levels. Due to the vast variety of the human antigen presenting molecules, identifying the immunogenicity of a vector is challenging, but essential. We apply a variety of assays in our search for antigenicity. These include an IFNg ELISpot assay, intracellular cytokine staining (ICS) and more recently an antigen presentation assay from ProImmune. With this approach we saw some encouraging results, which provide important information for future clinical trials.


Etiena Basner-Tschakarja, M.D., Ph.D., is a senior scientist at the laboratory of Prof. Katherine High of the Howard Hughes Medical Institute and The Children’s Hospital of Philadelphia. She is working on deciphering the cellular immune-response that was observed towards AAV capsid in a clinical gene transfer trial in humans. Her work includes overseeing the immune-monitoring of AAV gene transfer clinical trials and the validation of some of the utilized immune-assays.  Prior to joining Prof. High’s group she was working clinically in Dermatology and conducted research on the mechanisms of breaking immune-tolerance, at University Hospitals of Bonn and Cologne, Germany.

Dr. Basner-Tschakarjan is clinically trained in dermatology.

She received her degree at the University of Essen, Germany, and joined the laboratory of Eyal Raz, M.D.  at the University of San Diego, California for a post-doc, investigating the innate immune system in an allergy model. 



Sabine Zollner

CSL Behring


Preclinical characteristics of rVIII-SingleChain, a novel recombinant single-chain FVIII under clinical development at CSL Behring



The novel coagulation factor VIII molecule, rVIII-SingleChain, is composed of covalently bonded heavy and light chains to improve product characteristics, and thus FVIII therapy by enhancing molecular stability. The two-chain endogenous FVIII represents a labile configuration, although 95% of circulating FVIII is complexed with von Willebrand factor (VWF). This complex determines FVIII stability, its half-life and was shown to influence its presentation to the immune system. Yet, the unmet medical need for an improved FVIII therapy, that offers a reduced potential for immunogenicity combined with a more convenient dosing frequency is driven by a high incidence of inhibitory antibody development and an inherently short half-life of FVIII.

Non-clinical studies were conducted to investigate whether enhanced integrity can translate into improved pharmacological characteristics of rVIII-SingleChain in non-clinical models. In comparison to marketed two-chain, full-length rFVIII the binding affinity of rVIII-SingleChain for VWF and its stability were investigated in vitro. In animals, the PK properties of rVIII-SingleChain, its procoagulant activity and immunogenicity potential to induce anti-FVIII antibodies was explored.

Compared to full-length rFVIII, rVIII-SingleChain displayed a high affinity for VWF and a markedly enhanced molecular stability. Similarly, rVIII-SingleChain had more favorable PK properties, and thereby showed a prolonged thrombin generation potential and procoagulant activity. Furthermore, in FVIII knock-out mice rVIII-SingleChain induced a  lower anti-FVIII antibody response. This potential for reduced immunogenicity is investigated employing different ex vivo human immune model systems.

These non-clinical results warrant further exploration whether such improved molecular properties may translate into clinical benefit in hemophilia A patients


Sabine Zollner completed her doctorate at Philipps-University, Marburg, Germany in the Department of Virology. She then worked at Bayer Healthcare as a junior research scientist, working her way up to the Director of Antiviral Research. Following several managerial lab roles, Sabine is currently working as the Director of Product Development at CSL Behring AG in Switzerland. Her department focuses on various early and late stage research projects encompassing the development of plasma protein products, clotting factors and recombinant immunoglobulin molecules.

Takashi Kei Kishimoto, Selecta Biosciences

Selecta Biosciences


Rational design of tolerogenic nanoparticles for the prevention of anti-drug antibodies


The development of anti-drug antibodies (ADAs) is a common cause for treatment failure and adverse events associated with biologic therapies.  Selecta Biosciences is a clinical stage company that has developed a novel platform of Synthetic Vaccine Particles (SVP) to induce durable antigen-specific immune tolerance for the prevention of ADAs. Selecta’s tolerogenic SVP technology has the potential to improve efficacy and safety profile of novel biologics; reduce catastrophic late stage clinical failure due to ADAs; provide life cycle management for existing products; and differentiate products from biosimilars.


Jeremy Fry

Director of Sales, ProImmune, Oxford, UK.


Mastering immunogenicity: Tools and technologies


Developers of biologics recognize the need to understand the immunogenicity of their drug candidates, so that they can manage this risk. Of all the bioanalytical challenges faced in drug design and development, immunogenicity is probably the most important, but also one of the most complex and difficult issues to address. There are many technologies available to manage immunogenicity risk at a preclinical stage - but which should you choose?  I will give an overview of the tools and technologies for immunogenicity risk management, discussing how they can be applied.  These tools include antigen presentation assays to directly characterize HLA-associated peptides using Mass Spectrometry, Dendritic cell - T cell assays to measure responses to fully formulated biologics, physical HLA-peptide Binding Assays, and naïve T cell Proliferation Assays to quantify responses to individual epitopes.  I will also discuss how the potential risk of a cytokine storm first infusion reaction can be identified using whole-blood cytokine release assays.

Jeremy Fry gained his DPhil. from the University of Oxford developing gene therapy strategies to induce immunological tolerance in transplant recipients. Jeremy joined ProImmune to generate a new class of MHC multimer staining reagents. For the past 11 years as ProImmune's Director of Sales, he has led the sales team in a growing business, focusing on technologies that radically improve our understanding of immune responses.


Tim Hickling

Associate Research Fellow, Massachusetts, Pfizer, USA


Contribution of ex vivo assays to immunogenicity risk assessment


Tim Hickling is currently investigating the immunogenicity of biotherapeutics at Pfizer. He obtained his Biochemistry degree (1995) and Immunology Doctorate (1998) from the University of Oxford. He carried out post-doctoral training at Glaxo and the UK MRC’s National Institute for Medical Research before taking up a lectureship at the University of Nottingham, UK. Tim has worked on various aspects of innate and adaptive immunology in infectious and inflammatory diseases. Tim joined Pfizer in 2007 and has worked on early stage vaccines and from early discovery to late stage development of biotherapeutics


Nades Palaniyar

Senior Scientist, PGCRL, The Hospital for Sick Children and Associate Professor, Laboratory Medicine and Pathobiology, University of Toronto, Canada


Targeting innate immune collectins and neutrophil extracellular traps (NETs) to regulate inflammatory diseases



Innate immune collectins such as surfactant protein A (SP-A), SP-D, mannose-binding lectin and CL-11 are antibodies of the innate immune system. These collectins exert varying responses in circulation and mucosal surfaces, and certain collectins are known to improve immunogenicity of specific antigens. These collectins also interconnect microbes, antigens and dying cells to immune cells. However, the therapeutic potential of collectins has not also been fully explored. I will highlight the untapped therapeutic potentials of these proteins.

Recent studies have established that innate immune cells such as neutrophils release neutrophil extracellular traps (NETs). Emerging evidence indicate that NETs are major regulators of immunogenicity in many infectious, inflammatory and autoimmune diseases. Regulating NETosis is an important aspect in treating these diseases.

I will highlight the advances and therapeutic potentials of collectins and the prospective of regulating NETosis for altering immunogenicity and treating inflammatory diseases.


Nades Palaniyar has completed a PhD degree in Molecular Biology and Genetics at the University of Guelph, Canada (1997), focusing on viral DNA recombination. Subsequently, he worked on innate immune collectins at Guelph as a Postdoctoral Fellow, and identified several structural details of these proteins. He moved to the University of Cincinnati, USA (1998-2000), and as an American Lung Association Fellow, generated recombinant mice to study collectin structure and functions. As a Wellcome Trust-CIHR Postdoctoral Fellow at the University of Oxford, UK (2000-2004), he has identified the interactions between collectins and DNA. Currently, he is an Associate Professor at the University of Toronto and directs a research lab to study the functions of collectins and NETs. His current work focuses on identifying the therapeutic potential of collectins, and to identify molecular mechanisms regulating NETosis. He uses state of the art technology to uncover the therapeutic molecules for regulating NETosis for treating inflammatory diseases.

Joleen White



Evaluation of Peginterferon Beta-1a and Interferon Beta-1a Pharmacokinetics, Pharmacodynamics, and Immunogenicity in Multiple Sclerosis

Interferon beta has been successfully used to treat multiple sclerosis since 1993, with a variety of administration routes and frequencies among the approved products.  Interferon beta-1a IM is administered on a weekly schedule, and has an established safety and efficacy profile over 1.7 million patient years of exposure.  Peginterferon beta-1a is a novel molecular entity with covalent attachment of a single PEG moiety to interferon beta-1a, and was developed with the intent to reduce dosing frequency while maintaining the safety and efficacy profile of interferon beta-1a IM.

In Phase 1 trials in healthy human volunteers, peginterferon beta-1a demonstrated an extended half-life of 2-3 days compared to the 1 day observed with interferon beta-1a IM, resulting in greater exposure.  Peginterferon beta-1a also generated a higher magnitude and a longer duration of pharmacological response; neopterin elevation induced by peginterferon beta-1a  was more persistent compared with interferon beta-1a IM (approximately 10-14 days versus approximately 5 days).  The longer half-life and extended pharmacodynamic effect enabled dosing the therapeutic every 2 weeks and every 4 weeks in the pivotal phase 3 clinical study, as opposed to more frequent administrations performed for the non-pegylated IFN beta-1a products.

Pegylation has been associated with reduced immunogenicity rates for some proteins.  In the pivotal Phase 3 trial, immunogenicity against the interferon moiety of peginterferon beta-1a was lower than previously reported for other non-pegylated interferon beta-1a therapies; the incidence of persistent neutralizing antibodies was <1%.  The incidence of persistent anti-PEG antibodies was 3%.  No discernible impact of immunogenicity on clinical efficacy (primary and secondary endpoints) and safety was seen in this trial after 2 years of chronic treatment.


Joleen White is Principal Scientist in Translational Sciences at Biogen Idec. She earned a B.S. in Chemistry from Harvey Mudd College in 1997, and a Ph.D. in Biochemistry (Macromolecular and Cellular Structure and Chemistry) from The Scripps Research Institute in 2002. Prior to her position with Biogen Idec, she worked as Group Leader at Bristol-Myers Squibb Inc., Senior Scientist at BioMarin Pharmaceutical Inc., Scientist at ALZA Corporation (subsidiary of Johnson and Johnson), and Scientist at Thios Pharmaceuticals, Inc.

Throughout her career, she has applied her background in biophysical protein chemistry to pharmaceutical development in therapeutic indications with significant unmet medical need. In her current role, she supports method development and regulated bioanalysis of biomarkers, biopharmaceuticals, and immunogenicity in biological samples from nonclinical and clinical studies. Her experience with measuring macromolecules includes enzymes, monoclonal antibodies, Fc fusions, oligonucleotides, PEGylated proteins, and other novel protein constructs. She has supported studies from discovery through all phases of development including GLP nonclinical, clinical, and post-marketing commitments.

She is active in the international bioanalytical community, and served on the Global Bioanalysis Consortium by representing North America and large molecule bioanalysis on the Stability Harmonization Team. She has published 13 peer-reviewed manuscripts and 3 invited perspectives. She reviews manuscripts for Bioanalysis, Journal of Pharmaceutical and Biomedical Analysis, Journal of Immunological Methods, and AAPS Journal; and reviews poster abstracts for AAPS National Biotechnology Conference and AAPS Annual Meeting. She actively participates in local, national, and international conferences with 16 oral presentations, 3 coauthored oral presentations, and 5 symposia chairs.


Tudor Arvinte



Aggregates Phenomena that occur when therapeutic Proteins Solutions are mixed with human plasma and human blood: A new research and development field.

At present, major efforts are being made in the development of chemically and physically stable formulations of protein drugs, the stability being assessed in vitro, in the application container (e.g., vials, syringes, infusion systems). Formulations found to be not aggregated in such studies may form aggregates when mixed with human serum and human blood. Data from different biopharmaceuticals, including marketed monoclonal antibodies, will be presented showing that the aggregation in human serum and blood is dependent on the formulation.

Thus, using of wrong formulations carries a definitive risk of adverse events due to sub-micron and micron-size aggregates, such as blocking of blood capillaries and increased immunogenicity. This observation is new and important for the field of formulation research in the biopharmaceutical industry. The new data show that formulation optimization and development studies should also include the compatibility of the drug with human plasma, sera and blood.


Tudor Arvinte, Ph.D., received his academic training in physics at the University of Jassy, Romania, and his Ph.D. in biophysics from the University of Düsseldorf, Germany. He performed his doctoral work and postdoctoral stage at the Max-Planck-Institute West Germany and held numerous research positions in Europe and the USA: at C.N.R.S., Orléans, France, at Cornell University, New York, at Texas A&M University, and at the Biophor Corporation, College Station, Texas, USA. In 1989 he joined Ciba-Geigy Pharmaceuticals in Horsham, England, and in 1994 he moved to Ciba-Geigy in Basel, Switzerland. Until 2002 he worked as Head of Exploratory Formulation, Novartis Biotechnology Development & Production, Basel. T. Arvinte worked on the characterization and formulation of more than 130 protein and peptide drugs. T. Arvinte has over 80 publications and holds 13 patents on formulations of proteins: one patented formulation for hirudin is used in the marketed product. Since 2001 he is Invited Professor at the School of Pharmacy, University of Geneva, Switzerland where he is teaching a post-graduate course on “Formulation and delivery of protein biopharmaceuticals”. T. Arvinte is also Visiting Professor at the Department of Pharmacy, School of Health and Life Sciences King’s College London, UK. In 2003 T. Arvinte co-founded Therapeomic, Inc., a biotech company focused on developing formulations for biopharmaceuticals in collaborations with pharmaceutical companies.

Arlene Sharpe

Harvard University


T Cell Coinhibitory Pathways and Cancer Immunotherapy: Roles of the PD-1 pathway in controlling tolerance and tumor immunity.

The immune response plays an important role in fighting cancer; however, the tumor environment is immunosuppressive and limits effective anti-tumor immunity. A new and promising strategy of tumor immunotherapy blocks pathways used by tumors to inhibit anti-tumor immunity. This inhibitory strategy is called checkpoint blockade. One key immunoinhibitory pathway that inhibits tumor specific immunity is the PD-1 co-inhibitory pathway. This pathway consists of the PD-1 receptor and its ligands PD-L1 (B7-H1) and PD-L2 (B7-DC). The PD-1 pathway plays critical roles in maintaining immune control, and is a key mediator of T cell dysfunction (“exhaustion”) in cancer and chronic infections. This pathway is a promising therapeutic target in cancer.  The remarkable effects of PD-1 pathway blockade in cancer demonstrate the key role of this pathway in inhibiting anti-tumor immunity. However, there are multiple co-inhibitory pathways that that limit T cell function, and these have become targets for cancer therapy. This talk will discuss the multifaceted immunoregulatory roles of PD-1 and its ligands in controlling T cell activation, tolerance and exhaustion.  The role of the PD-1 pathway in cancer as well as therapeutic strategies that combine PD-1 blockade with other therapies also will be discussed.

Arlene Sharpe M.D. Ph.D. is the George Fabyan Professor of Comparative Pathology, Head of the Division of Immunology in the Department of Microbiology and Immunobiology, and Co-Director of the Harvard Institute of Translational lmmunology at Harvard Medical School, and a member of the Department of Pathology at Brigham and Women’s Hospital. Dr. Sharpe is the Co-Director of the Evergrande Center for Immunologic Diseases at Harvard Medical School and Brigham and Women’s Hospital. Dr. Sharpe is a leader in the field of T cell costimulation, and investigates how costimulatory pathways regulate immune responses. Her laboratory has discovered and elucidated the functions of T cell costimulatory pathways, including the immunoinhibitory functions of the CTLA-4 and PD-1 pathways, which have become exceptionally promising targets for cancer immunotherapy. Her laboratory currently focuses on the roles of T cell costimulatory pathways in regulating T cell tolerance and effective antimicrobial and antitumor immunity. Her laboratory also is involved in studies aimed at translating fundamental understanding of T cell costimulation into new therapies for autoimmune diseases, chronic viral infections, and cancer.

Susan Kirshner



Therapeutic Proteins: Routes of Exposure and the risk of immunogenicity

Immunogenicity risk management includes risk assessment and risk mitigation strategies.   Knowledge about immune mechanisms is critical for improving the accuracy of risk assessments as uncertainty in knowledge about a risk factor increases its risk categorization.  This talk will explore the impact of sub cutaneous, intra venous, and oral routes of exposure on the immunogenicity of therapeutic proteins.


Dr. Susan Kirshner received an MSc from University of North Carolina School of Public Health in the field of environmental toxicology.  She received a Ph.D. in Immunology from the Weizmann Institute of Science, where she worked on the development of a peptide therapeutic for the treatment of the autoimmune disease Myasthenia Gravis.  Dr. Kirshner’s post-doctoral training was at the National Cancer Institute in the area of transcriptional regulation of MHC class I genes.  Dr. Kirshner worked both in the government and industry before joining the Division of Therapeutic Proteins in the Office of Biotechnology Products at the US FDA almost 12 years ago.  She is currently the Review Chief in the Division of Therapeutic Proteins.

Amy Loercher


 ABIRISK Developments and Challenges: Perspectives from Year 2

The Innovative Medicine Initiative’s Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk (ABIRISK) project has made significant progress in its second year.  This presentation will provide an overview of current developments with a focus on anti-drug antibody and neutralizing antibody assays provided for the analysis of retrospective and prospective cohorts.


Dr. Amy Loercher is a manager in the GSK Clinical Immunology group with almost 10 years of experience in immunogenicity assay development and validation.

Bonnie Rup

Immunogenicity Sciences, Pharmacokinetics Dynamic and Metabolism at Pfizer, Andover, MA, USA

Roundtable discussion moderator

Bonnie Rup works in the Pharmacokinetics, Dynamics and Metabolism-New Biological Entity (PDM-NBE) organization at the Pfizer Andover Massachusetts site where she leads the PDM-NBE Immunogenicity Discipline, which supports immunogenicity risk assessment for the R&D portfolio.  She is co-chair of the Pfizer Immunogenicity Expert Working Group and serves on Pfizer’s Biotherapeutics Advisory Council. 

Bonnie was previously Assistant Vice President of Protein Bioanalytics in Wyeth, responsible for developing and applying immunoassays and other ligand binding methods to characterize PK and ADA response from discovery through post-marketing and Drug Safety and Metabolism Therapeutic Area Head for Wyeth’s Hemophilia Products.  Previously she held various positions in Wyeth, Genetics Institute and Monsanto/Searle.  She received a B.S. in microbiology from the University of Massachusetts, Amherst and a Ph.D. in the area of viral immunology from the Microbiology Dept, University of Texas, Austin, after which she held postdoctoral positions at Duke University and the University of Rochester, NY, studying viral and cellular immunology. 

Bonnie is an active member of the American Association of Pharmaceutical Sciences (AAPS) Immunogenicity of Therapeutic Proteins Focus Group (Co-founder, Past Chair, current Steering Committee Member) and is a past chair of the AAPS Ligand Binding Assay Bioanalytical Focus Group, and a member of BioSafe and European Immunogenicity Platform.  With several of these organizations, she has been a co-author for publications related to for monitoring the immunogenicity of therapeutic proteins. 

Continuing the discussion

Following the original 2011 Mastering Immunogenicity meeting, we set up a LinkedIn group, to share information and foster debate on immunogenicity risk management.  We hope it provides a useful forum for continuing the discussions initiated at this meeting.


Join our Mastering Immunogenicity LinkedIn Group


The British Consulate-General, Boston, Massachusetts

British Consulate-General, One Broadway, Cambridge, Massachusetts 02142, USA
Telephone: +1 (617) 245 4500

The British Consulate-General Website


Previous conference attendees and participants include


Comments from Mastering Immunogenicity 2013 Tim Hickling, Pfizer:
“Mastering Immunogenicity captured breadth and depth of immunogenicity issues faced by industry today” Caroline Barelle, University of Aberdeen:
“It was a great chance to speak to leaders in the field and I certainly came away with a lot of ideas and considerations for our platform. There was something for everyone and I truly believe we all left learning something new”
Valerie Quarmby, Genentech:
“It was a terrific event, with excellent speakers and great networking/brainstorming opportunities at the breaks and with the roundtable” Sam Pine, Allergan:
"I also found the conference immensely informative and useful. The intimate size was a pleasant change from most conferences, and the participants were engaged and had much to contribute." Marisa Joubert, Amgen:

“Thank-you for including me in this important event. I really enjoyed all of the presentations and off-line discussions as well. I hope to participate in this meeting in the future!”


Karl Griswold, Dartmouth University:
"What a great event!  The speakers were all fantastic, and though I listened more than participated in the round table discussion, I thought it was also immensely informative. The two days were the best educational experience I’ve had in a while."


Continuing the Discussion

Following our first Mastering Immunogenicity meeting in 2011, we set up a LinkedIn group, to share information and foster debate on immunogenicity risk management. We hope it provides a useful forum for continuing the discussions initiated at this meeting.

Join our Mastering Immunogenicity LinkedIn Group

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The city of Boston is an international center of higher education and a center for medicine and biotechnology, and consequently is a fitting location for ProImmune's 'Mastering Immunogenicity' conference.

As you join the lively and productive discussions during the two days of our event, we trust you will also find time to enjoy the sights and atmosphere of one of the oldest cities in the United States. Boston is as close to the Old World as the New World gets, an American city that proudly trades on its colonial past, having served a crucial role in the country's development from a few wayward pilgrims right through to the Revolutionary War.

No other city in America gives a better feel for the events and people behind the nation's birth, all played out in Boston's wealth of emblematic and evocative colonial-era sights. Equally alluring are the city's attractive public spaces, and the diversity of its neighbourhoods – student hives, ethnic enclaves, and stately districts of preserved townhouses.

Biotechnology/Life Sciences

Discoveries are made every day in the labs of Cambridge's biotechnology corporations, which make up nearly one-third of Massachusetts's biomedical companies. Cambridge has established itself as the epicentre of the world's biotechnology industry, currently hosting over seventy biotech companies which employ more than 10,000 people, including leading-edge companies such as Amgen, Biogen IDEC, Vertex, Genzyme, Shire, Pfizer, Momenta Pharmaceuticals and the prestigious Whitehead Institute. The cluster of biotechnology companies in Cambridge, specifically in the Kendall Square area, has earned it the nickname "Genetown."

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Accomodation and Travel

Delegates are responsible for arranging their own accommodation. The following are suggested options for accommodation in the vicinity of the British Consulate-General (One Broadway, Cambridge Massachusetts 02142, USA).

Royal Sonesta Hotel (within easy walking distance of the venue), 4 Stars
40 Edwin H. Land Blvd.
Cambridge MA 02141

Marlowe, a Kimpton Hotel, 4 Stars
25 Edwin H Land Blvd
Cambridge MA 02141

Best Western Hotel Tria, 4 Stars
220 Alewife Brook Pkwy
Cambridge MA 02138

Hyatt Regency Cambridge (near to the venue), 3.5 Stars
575 Memorial Dr.
Cambridge MA 02139

Courtyard by Marriot Boston-Cambridge (near to the venue), 3 Stars
777 Memorial Dr.
Cambridge MA 02139

Holiday Inn, Boston-Somerville
30 Washington Street
Somerville MA 02143



Full details of how to get to the venue, and a map, can be found here.


Directions by Road

From the West:

  • Take Mass. Pike East
  • Exit 18 to Cambridge (the exit is on the left)
  • After paying the $1.00 toll the road splits; bear right off the ramp
  • Turn right at Massachusetts Avenue
  • Turn left onto Vassar Street; road becomes Galileo Galilei Way
  • Turn right at Broadway, then make a left at 3rd Street to access the British Consulate-General's parking garage


From the South:

  • Take 93 North
  • Take the Storrow Drive Exit
  • Follow ramp - it will split, stay on the right and you will go under a short tunnel
  • Get into the left lane and go UP the first ramp on the left
  • At the end of the ramp, turn right and go over the Longfellow Bridge
  • Continue on Main Street
  • Bear right to stay on Broadway and make an immediate right turn on 3rd Street to access the building's parking garage


From the North:

  • Take 93 South
  • Take the Storrow Drive exit
  • Follow directions as coming from the South


From Logan Airport:

  • Follow signs to Summer Tunnel
  • Go through tunnel and stay to the left
  • Take the Storrow Drive exit
  • Follow directions as coming from the South


Daytime parking
Parking is available for visitors at the following rates. The garage is accessible via the 3rd Street side of the building.

Monday through Friday, for arrival between 6:00am - 4:00pm
0-15 minutes Free
1 hour or less $5
2 hours or less $10
3 hours or less $13
Between 3-10 hours $15
Between 10-24 hours $18

Evening parking
For arrival after 4:00pm until close $5
(Any exit after 10:00pm incurs a fee of $18)


Directions by Rail

Red Line: the venue is located convenient to the Kendall Square Stop.

The Red line is the primary subway line serving Cambridge. Stops within the city include, from west to east, Alewife, Davis (in Somerville), Porter, Harvard, Central and Kendall/MIT. Trains run regularly throughout the day, starting at approximately 5:15 a.m. weekdays and Saturdays, 6 a.m. on Sundays, and at intervals of ten to 14 minutes (except during rush hour, when trains run every seven or eight minutes), until approximately 12:15 a.m. the following morning. The current fare on the Red Line is $2.00 with a Charlie Card or $2.50 with a Charlie Ticket.

From the MBTA (Massachusetts Bay Transit Authority) (leaving Park Street):

  • Take the Red Line heading toward Alewife
  • Get off at Kendall Square
  • Walk down Main Street towards the city of Boston
  • Cross over Broadway; the Consulate is located in the tall beige building with a Dunkin’ Donuts in the lobby


All Conference Enquiries


Telephone (toll free): USA & Canada +1 888 505 7765
All other countries +44 (0) 870 042 7279

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