Sunday, January 12 | 5:00-8:00 pm
SC1: Targeting of GPCRs with Monoclonal Antibodies - Detailed Agenda
While GPCRs (G protein-coupled receptors) are important therapeutic targets, it has been challenging to discover therapeutically relevant antibodies against them. This course will examine different steps along the anti-GPCR antibody discovery pathway and highlight various approaches to accomplishing each step. The topics to be covered include: 1) antibody discovery, including methods to generate antibodies and antigen preparation; 2) assays to evaluate antibody binding using cells expressing the GPCR of interest; 3) in vitro assays to measure functional activity of the antibody, including antagonism, agonism, or synergism/allosteric modulation using chemotaxis, calcium, cAMP or other cell-based assays; and 4) review of promising GPCR targets and therapeutic antibodies currently in clinical development.
Barbara Swanson, Ph.D., Director, Research, Sorrento Therapeutics, Inc.
SC2: Antibody Humanization via One Hot Homology Model (Hands-On) Workshop - Detailed Agenda
Recent advances in antibody homology modeling have led to the creation of different strategies to design, engineer and affinity mature as well as humanize antibodies. In silico modeling not only helps in better antibody design but also saves time from predictions to validation.
Vinodh Kurella, Ph.D., Visiting Research Fellow, C3 Bioinformatics, Harvard Medical School
SC3: Vaccine Formulation and Characterization, Status Quo and New Opportunities - Detailed Agenda
After water sanitization, vaccines may be the most successful method to prevent deadly or devastating infectious diseases. To overcome the hurdles that reduce vaccine efficacy, novel techniques to identify and improve vaccines are necessary. These new approaches help increase potency but also challenges related to formulation characterization and the stability of each component. The course will describe the current status of vaccine formulation characterization with a focus on alum-based formulations and describe steps that can improve it.
Michele Pallaoro, Ph.D., Unit Head, Formulation Analytics, Novartis Vaccines & Diagnostics
SC4: QbD Strategies for Formulation Development of Protein Therapeutics - Detailed Agenda
The course will discuss how to perform protein formulation development to meet QbD expectations from the health authorities. Case studies will be presented on how to conduct Force degradation and stability-indicating analytical methods, design DOE and multivariate experiments and how to analyze data.
Kevin Zen, Ph.D., Manager, Biologics Development, Allergan
Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.
SC5: Advances in Cell Line Engineering - Detailed Agenda
Discovering and designing novel therapeutic monoclonal antibodies (mAb) is just the beginning. The expanding demand for high-quality antibodies with better specificities has resulted in significant improvements in traditional hybridoma and genetically modified cell line engineering and production methods. However, these newly formed hybridomas and cells often grow poorly or die, and their selection and cloning are laborious and time-consuming. This course is designed to explain recent advances in cell line engineering technologies and provide practical examples through case studies.
Robert Horlick, Ph.D., Senior Director, Molecular Biology, AnaptysBio, Inc.
Takeshi Omasa, Ph.D., Professor, Institute of Technology and Science, University of Tokushima
Additional Instructors to be Announced
SC6: Strategies for Purifying Proteins: Optimizing Buffers and Overcoming Aggregation - Detailed Agenda
This course will provide strategies for purifying proteins, such as identifying and overcoming aggregation and stabilizing proteins through buffer optimization, including analyzing quality, pH, salt, stabilizing elements, buffering systems and identifying solubility-promoting buffers.
Sarah Bondos, Ph.D., Assistant Professor, Molecular & Cellular Medicine, Texas A&M University
Mark Arbing, Ph.D., Director, Protein Expression Technology Center, UCLA-DOE Institute for Genomics & Proteomics
Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
SC7: Technical Diligence and QbD for Implementation of Single-Use Systems - Detailed Agenda
The course will focus on Technical Diligence as part of a QbD-inspired implementation process for Single-Use Systems (SUS) as defined by the PDA Technical Report on SUS. Technical Diligence is the means by which the technical capabilities of the SUS, the raw materials, its supplier and its fit with the end user are verified. Part of process validation and verification, it is applied as the first step in a quality audit programme and becomes a recurring theme over the implementation process and subsequent routine procurement.
Stephen W. Brown, Ph.D., CTO and Executive Director, Technical Development, Clinical Manufacturing Unit, Nantes, BE Vaccines SAS
Tuesday, January 14 | 5:00-8:00 pm
SC8: Selection of New Antibodies with Improved Properties - Detailed Agenda
The ability to identify antibodies that have the required potency and specificity is the essential first step in any drug discovery effort. Additionally these molecules need to have the biophysical properties that make them suitable candidate therapeutic molecules. The identification of antibodies with “drug-like” properties can be achieved through an understanding of the characteristics of the ideal drug candidate and tailoring the selection process to meet this specification.
Andrew E. Nixon, Ph.D., Vice President, Discovery Research, Dyax
SC9: In silico Immunogenicity Predictions (Hands-On) Workshop - Detailed Agenda
Computational immunogenicity predictions for antibodies as well as pathogens help in the rational design and re-engineering. This facilitates the minimization of anti-drug antibodies (ADA) as well as better vaccine design. The latest in silico tools can shorten the process from design to preclinical validations.
Vinodh Kurella, Ph.D., Visiting Research Fellow, C3 Bioinformatics, Harvard Medical School
SC10: Protein Aggregation: Mechanism and Characterization - Detailed Agenda
We will discuss the phenomena described by protein aggregation, how aggregates form, what factors influence their formation and consequences of aggregate formation. We will also discuss how to predict aggregation and key analytical challenges and tools for characterization of aggregates.
Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and Physical Pharmacy, Purdue University
Daniel Some, Ph.D., Principal Scientist, Wyatt Technology
SC11: Extractables and Leachables: Applications to Final Packaging and Single-Use Systems - Detailed Agenda
The course will outline fundamentals to material chemistry and leachable sources, while also highlighting properties that govern migration of compounds. Case studies will be presented on how to develop evaluation strategies and design appropriate analytical studies for Controlled Extractables Testing, Leachables Studies and Tox Assessment.
Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC
John Iannone, Program Manager and Technical Specialist, Toxikon Corporation
SC12: Transient Protein Production in Mammalian Cells - Detailed Agenda
We will introduce the fundamental concepts needed to establish transient protein production (TPP) in mammalian cells. TPP allows for the rapid generation of milligram to gram quantities of recombinant proteins for therapeutic, functional and structural studies. This course will provide an introduction to TPP through instruction and case studies in an interactive environment.
Richard Altman, MS, Research Scientist, Alexion Pharmaceuticals
Henry C. Chiou, Ph.D., Senior Product Manager, Life Technologies
Krista Johnson, MSc, Research Scientist, Alexion Pharmaceuticals
SC13: Sample QC: Aggregation and Beyond -- Buffer Optimization: Approaches and Applications -- Detailed Agenda
This course will focus on implementing a buffer “optimization” screen into a core service protein expression lab. We will look at assay development, how the assay dovetails with a micro-scale purification platform, how the results of the screen are interpreted and, ultimately, what real benefits are gained by the approach. In addition, we will compare methods for measuring proteins’ melting temperature and examine characterization of protein-ligand interactions.
William Gillette, Ph.D., Senior Scientist, Protein Expression Lab, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research
Andrew Stephen, Ph.D., Senior Scientist, Protein Expression Lab, Cancer Research Technology Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research
SC14: Challenges of Multi-Column Continuous Chromatography - Detailed Agenda
MCC chromatography in sequential and countercurrent mode has become an attractive tool to overcome the “bottleneck.” Although the SMB technology has a proven record in the manufacture of synthetic pharmaceuticals, barriers still remain to implement the technology into the biopharmaceutical industry.
Dr.-Ing. Kathleen Mihlbachler, Independent Consultant
* Separate registration is required.