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In Progress

Antibody Drug Conjugate Development & Production

Antibody Drug Conjugate Development & Production

Antibody Drug Conjugate
Development & Production

Monday, March 30, 2015 and Tuesday, March 31, 2015

Capitalizing on recent industry achievements, this track will showcase how companies are successfully implementing novel approaches to improve the development, scale up, formulation, production and transfer of ADCs. Starting with the most recent accomplishments in R&D and the clinic, this track will explore the evolution in development to produce the next generation of ADCs that are more potent, stable, and have dramatically increased therapeutic windows.

» Download Agenda | Register Now

Session Highlights

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

Antibody Drug Conjugate Development & Production

Monday, March 30, 2015

Registration and Coffee

Keynote Presentations

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

Presentation TBA

Dana Andersen, Ph.D. Challenges and Opportunities in Pharmaceutical Development
Increasing needs to improve the efficiency of development together with new opportunities such as Breakthrough Therapy designation, will require novel approaches and innovations to be successful. Specific examples and opportunities will be discussed focusing on drug product development but many of which are more broadly applicable as well.
Dana C. Andersen, Ph.D., Senior Director, Pharmaceutical Development, U.S. Biologics Technical Development, Genentech - a Member of the Roche Group

Networking Refreshment Break in Poster and Exhibit Hall

Chairperson's Remarks
Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas

Quality and Regulatory Considerations for ADCs

Regulatory Considerations for ADC Development - Regulatory Reviews, CMC Challenges, and Non-Clinical Requirements
Because ADCs have both small and large molecule components, the Quality (or CMC) requirements are multi-faceted. This session reviews the major regulatory considerations and issues for ADC's with emphasis on CMC challenges during early development (pre-IND through Phase 2) including a review of the general guidance for both biologics and new chemical drugs (FDA, EMA and ICH) that apply well to ADC's. Nonclinical study requirements are also discussed.
Karen Cha, M.A., MBA, Director, Regulatory Affairs, Agensys, Inc.

Strategies for Setting Specifications for ADCs
Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc.

Impact on New Linker Payloads on Drug Substance Quality Attributes and Process Solutions
Olivier Marcq, Ph.D., Senior Principal Scientist, Pfizer Biotherapeutics R&D, Pfizer

Technology Workshop Presentations

Single-Use Fermentation: Understanding Process Economy and Process Performance
The entry of single-use bioprocessing and the benefits that come with disposables have generated interest in the microbial community. This talk will present results from a process economy comparison of fermentation scenarios based on stainless steel and single-use equipment. Additionally, data will be shown from a wet-work study of an E.coli domain antibody production using stainless steel and disposable equipment.
Kenneth P. Clapp, M.S., Senior Product Manager, Bioreactors & Fermentors, GE Healthcare Life Sciences / Xcellerex

Fit For Purpose – Design and Implementation of Single-Use Bioprocessing Plants
Flexibility and speed are important factors for clinical manufacturing. Most of the biopharmaceutical manufacturers have initiated programs to investigate alternative ways to produce clinical material in order to improve these two requirements. However there are essential matters which have to be considered during implementation. In this contribution case studies of successfully executed fast track projects for Phase I-III material will be shown.
Dr. Thorsten Peuker, VP Integrated Solutions, Sartorius Stedim Biotech

Using Process and Activity to Drive Clone Selection
During a manufacturing CHO stable cell line development project, it was observed that the product being made by the CHO clones displayed a significant reduced specific activity when compared to a reference standard. This case study highlights how the lack of activity was identified and how the development of a cell culture process enabled the identification of high productivity clones.
Oren E. Beske, Ph.D., COO, Aragen Bioscience, Inc

Networking Luncheon in Poster and Exhibit Hall

Chairperson's Remarks
Ian Schwartz, M.S., Senior Engineer, ADC Process Development, Agensys, an affiliate of Astellas

New Modalities and Next Generation ADCs - Challenges in Development and Production

Development of a Site-Specific Conjugation Process Applicable to Monoclonal and Bispecific Antibodies
Industry is under pressure to decrease development timelines for antibody drug conjugates. We describe the development strategies and site specific conjugation processes for both monoclonal antibody and bispecific antibody conjugates. Harmonization of the process development work led to the quick delivery of high quality conjugates by identifying important process parameters and using similar materials and analytical tools.
Ellen O'Connor, Ph.D., Senior Scientist, MedImmune

Producing Homogeneous Site Specific ADCs using Xpress CF+
Using Xpress CF+, hundreds of non-natural amino acid antibody variants are made within a day. Using fast, quantitative conjugation chemistries, e.g. Click Chemistry/Reverse Diels-Alder, antibodies are conjugated within hours with low molar excess of linker warhead. The best sites are selected based on expression, cell binding, conjugation efficiency (DAR), and cell killing. In vivo efficacy, PK/PD, and stability studies further winnow to our best ADC candidates. Multiple ADC examples will be provided that illustrate the power of this platform.
Aaron Sato, Ph.D., Vice President, Research, Sutro Biopharma Inc.

Probody Drug Conjugates (PDCs): A Path to Safer and More Effective ADCs
Sridhar Viswanathan, Ph.D., Vice President, Process Sciences & Manufacturing, CytomX Therapeutics, Inc.

Networking Refreshment Break in Poster and Exhibit Hall

New Modalities and Next Generation ADCs - Challenges in Development and Production (continued)

A Versatile, Modular Approach to Building Customized, Site-Specifically Conjugated ADCs using SMARTag™ Technology
We will present our novel protein modification platform and its application to generating site-specifically modified ADCs, using our new conjugation chemistries and linker libraries. Additionally, we will highlight data demonstrating SMARTagTM ADC efficacy in preclinical tumor models, stability in PK studies, and safety in toxicity studies, and discuss how these parameters are impacted by payload placement on the antibody.
Penelope M. Drake, Ph.D., Biology Group Leader, Catalent Biologics - formerly Redwood Bioscience

Robert Lutz, Ph.D. Clinical Development of ADCs - How are We Doing?
A look at the ADC report card after two decades of clinical development: This talk will highlight the successes and challenges being encountered with current technologies and discuss what is coming through the pipeline to improve the probability of success.
Robert Lutz, Ph.D., Vice President, Translational Research & Development, ImmunoGen, Inc.

Controlled Conjugation Strategies and the Preparedness of CMOs and Internal Facilities for New Linker/Payloads and Processing Strategies
Moderator: Michael Sun, Ph.D., Seattle Genetics, Inc.
Olivier Marcq, Ph.D., Pfizer
Ellen O'Connor, Ph.D., MedImmune
Aaron Sato, Ph.D., Sutro Biopharma Inc.
Ian Schwartz, M.S., Agensys, an affiliate of Astellas
Jason Brady, Director, Lonza
Mary Robinette, Sigma Aldrich

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

Registration and Coffee

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

Analytical Characterization for ADCs

Yan Chen, Ph.D. Overcoming Analytical Challenges during Development and Production of ADCs
Current conjugation process often produces a heterogeneous product. Analytical characterization for these complex ADC molecules can be challenging and requires a variety of techniques. Examples will be provided to demonstrate that the selection of the most appropriate methods for a specific ADC depends on the nature of the drug-linker, the mode of attachment, and the resulting complexity of the product.
Yan Chen, Ph.D., Technical Development Senior Scientist, Protein Analytical Chemistry, Genentech, Inc.

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

Advances in the Analysis and Characterization of ADCs
Oscar Salas-Solano, Ph.D., Senior Director of Analytical Sciences, Seattle Genetics, Inc.

Networking Refreshment Break in Poster and Exhibit Hall

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

Process Development Approaches

Orthogonal Analytical Characterization in Supporting Process Development
Process development for bioconjugates is complex and challenging. Conventional analytical tools may not be sufficient in providing information needed for process optimization. Size exclusion chromatography (SEC)-HPLC is the workhorse for evaluate molecular size during the process monitoring. However, even with current column separation technology, desired resolution may not be achieved for some either rather large or very heterogeneous molecules. This presentation will highlight the application of some column-free separation techniques to facilitate the size characterization for bioconjugates.
Qin Zou, Ph.D., Senior Principal Scientist, Pfizer, Inc.

Raw Material Variability - Assessing Quality of Polysorbate in the Formulation of ADCs
Polysorbate is a surfactant commonly used in the formulation of biologics to prevent the formation of aggregates and protect against denaturation. Assessing the quality of polysorbate raw material is a challenge given its inherent heterogeneity. In this presentation we will discuss results of a comparability study with polysorbates obtained from two different manufacturers.
Sonia Taktak, Ph.D., Analytical Scientist III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

A Novel Antibody Drug Conjugation Method UsingAmbrx's EuCode™ Technology and Its Application inProduct Development - Case Studies of Conjugation Development and Scale-Up for Clinical Manufacturing
Ambrx's EuCode™ technology, which has been successfully proven at clinical stage for non-ADC products, offers unique advantages in producing site-specific ADC with precise control of payload per mAb ratio. Ambrx's EuCode™ technology will be presented in detail as to its superior application in making fully controlled and homogeneous ADC products. Case studies on development of conjugation process and process scale-up for clinical manufacturing will be presented. Additionally, in vitro and in vivo data will also be presented to demonstrate the impact of conjugation site, type of drug and payload to mAb ratio on ADC potency and pharmacokinetics.
Yun Bai, Ph.D., Associate Director, Process Development, Ambrx Inc.

Technology Workshop Presentations

New Low Shear Force Single-Use Pump System enables High Cell Viabilities, Protein Activities and a Safe, Pulsation Free Conveyance of Sensitive Biotech Media
Cells and proteins used in today's Biotech processing can be very sensitive to external mechanical forces such as shear stress. Commonly used technologies as peristaltic pumps can cause severe influence on cell viability or protein activities. This workshop introduces a new pump technology applying magnetic levitation for a safe, pulsation free conveyance of sensitive biotech media. Current research at the ZHAW University Zurich reveals astonishing results comparing the influence of different pump systems to cells and proteins which will be shared during the presentation.
Wolfgang Dornfeld, MSc, BSc, MBA, VP Field Operations, Levitronix GmbH
Ina Dittler, MSc, Research Asst, School of Life Sciences & Facility Management, Zurich University of Applied Sciences

Agile Development of a Biobetter ADC: A Case Study
Antibody-drug conjugates (ADC's) represent a promising therapeutic approach combining the antigen-targeting specificity of monoclonal antibodies (mAbs) with the cytotoxic potency of chemotherapeutic drugs including the essential linkers. Creating a vertical hierarchy will allow agile benefits such as high levels of product customization, stringent quality control, shorter development and production spans, and economies of scale. EirGenix and Formosa Laboratories have formed an alliance that provide for all components of ADC drug development. Through the implementation of this agile hierarchy they have developed a unique Bio-better.
Molly McGlaughlin, VP Business Development, EirGenix

Networking Luncheon in Poster and Exhibit Hall

Chairperson's Remarks
Michael Sun, Ph.D., Director, Purification & Conjugation Development, Seattle Genetics, Inc.

Formulations and Fill/Finish for ADCs that are More Potent and Less Stable

ADC Formulation Development
ADCs have unique attributes that are affected by the nature of the component parts: the antibody, the linker and the toxin. The attributes are affected by the formulation, the process parameters, and the storage conditions. Effective formulation development strategies are based upon a molecular understanding of the ADC: aggregates, charge variants, DAR, conjugation site, free drug, various degradation pathways. Development of ADCs requires an array of analytical and biophysical techniques that are used to identify attributes that could have a clinical impact.
Janet Wolfe, Ph.D., President, Wolfe Laboratories

Conjugation & Fill/Finish: A New Concept Applied to the Supply Chain of ADCs - from Earlier ConjugationDevelopment to GMP Commercial Manufacturing
Maria Elena Guadagno, Ph.D., Business Director, BSP Pharmaceuticals, Italy

Networking Refreshment Break in Poster and Exhibit Hall

Scale Up, Facility Fit & Implementing Single-Use Systems for Manufacturing ADCs

Rapid Scale Up and Facility Fit for a Mammalian Cytokine Developed in E.coli that was Destined to be Part of a Bioconjugate
Shuang Chen, Ph.D., Principal Scientist, Pfizer Inc.

Manufacturing ADCs Utilizing Full-Disposable System
Jason Brady, Director, Sales and Business Development, Lonza

Single-Use Applications for ADCs
Mary Robinette, Process Lead, Engineering, Sigma Aldrich

Close of Day Two

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.
Co-Sponsored by: and

BPI 2015
Charles River

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