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PepTalk 2012 Brochure


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SUNDAY, January 8 Dinner Short Courses - 5:00 - 8:00 pm

SC1: Characterization and Analysis of Sub-Visible Particulates

Sub-visible particles present in these biopharmaceutical products are a product quality attribute and a potential patient safety concerns yet to be fully explored. Early and consistent particle detection, quantitation and control throughout the product life cycle of these drugs from development to commercial lot release is critical in mitigating any concerns. This requires appropriate analytical methods which can be applied to biopharmaceuticals across a large variety of protein concentrations and modes of administration. This workshop and interactive discussion will cover strategies to utilize complementary methods and techniques at different phases of product development.

Instructors to be Announced.


SC2: Protein Purification Kits and Packages

What is available to simplify downstream processing? This course will examine what are the best protein purification aids on the market, how they work, and how much they cost. The course will also include buffers and reagents in order to provide the most comprehensive look at purification kits and technologies.

  • Kits for His Tag / GST Tag / Strep Tag Affinity / Protein A
  • Additional kits for antibody purification
  • Compare and contrast products on the market

Instructors to be Announced.


SC3: Biosimilars

As more biologics come off patent, the world of biosimilars (ie. follow-on biologics) is emerging to exploit exposed opportunities. This course will provide insights into key considerations surrounding the development and approval of biosimilars.

  • Regulatory guidelines
  • Tools for characterizing biologics
  • Is the process the product?
  • Where are biosimilars headed, and how will they affect the biologics field?

Instructors to be Announced.


SC4: Transient Protein Production in Mammalian Cells: A Short Story

This short course will introduce the fundamental concepts needed to establish transient protein production in mammalian cells. This will allow for the rapid generation of milligram to gram quantities of recombinant proteins for therapeutic, functional, and structural studies. The course will combine instruction and case studies in an interactive environment.

  • A brief overview of protein expression systems
  • An in-depth introduction to mammalian transient expression systems
  • Examination of the key elements necessary for the establishment of a mammalian transient production system
  • Scalable transient protein production
  • Optimizing the transient protein production process

Instructors:

Richard Altman, Ph.D., Research Scientist, Alexion Pharmaceuticals

Dominic Esposito, Director, Protein Expression Laboratory, SAIC-Frederick, Inc.

TUESDAY, January 10 Dinner Short Courses - 4:30 - 7:30 pm

SC5: How to Obtain Reliable Information from DLS and Multi-Detector SEC Systems for Biophysical Characterization

Since its market introduction circa 30 years back, dynamic light scattering (DLS) has occupied a position of increasing popularity within the area of protein aggregate detection and characterization, due in large part to the non-invasiveness of the technique, the minimal sample volume & concentration requirements, and the quickness of data collection. While modern instrument design and software have removed much of the mystique traditionally associated with the technique, data interpretation is still an area of frustration for many DLS users. This workshop covers the basic theory behind DLS instrumentation, with a focus on the do¡¯s & don¡¯ts when it comes to data interpretation.

Instructors:

Kevin Mattison, Ph.D., Principal Scientist, Bioanalytics, Malvern Instruments

Ulf Nobbmann, Ph.D., Senior Applications Specialist, Nanometrics, Malvern Instruments

Jason Sanchez, Ph.D., Separations Product Specialist, Malvern Instruments


SC6: A Practical Guide to the Use of Affinity Tags for Protein Purification

Affinity tags are a great tool for purifying protein. This course will provide an overview of affinity tags, how they function, and which ones fit which protein best. If you want to learn about affinity tags, this course is perfect for you.

  • Which tag is best for your protein?
  • Comparison of the available affinity tags
  • Case studies of affinity purifications
  • Getting rid of affinity tags

Instructors to be Announced.


SC7: Optimized Strategies for Therapeutic Antibodies Discovery and Engineering

This course will introduce a general work flow of an antibody project from preparation for its launch to having the drug candidates with an emphasis on selecting the proper discovery and engineering tools to achieve the intended goal. Topics to be discussed include:

•Antibody generation project from an antibody engineer¡¯s point of view
•Antibody generation campaigns: discovery and engineering antibody leads.
•Antibody drug-like properties: active engineering or passive screens?

Who Should Attend?
Anyone who is interested in having a better understanding of how an antibody drugs are made.

Instructor: Chung-Ming Hsieh, D.Sc., Associate Director, Antibody Generation Group, Abbott Bioresearch Center


SC8: Harnessing CHO Cells: The Work Horses of Bioproduction

Chinese hamster ovary (CHO) cells are the predominant cell factory for the production of biotherapeutics. Nevertheless, even with the recently released CHO cell DNA sequence, more research is required to harness their production potential. This interactive short course is designed to provide practical solutions for CHO cell lines including:

  • Sequencing and characterization
  • Engineering and stability
  • Transfection and production
  • Culture and media

Instructors:

Kelvin H. Lee, Ph.D., Professor, Chemical Engineering, Director, DE Biotechnology Institute, University of Delaware

Hisahiro Tabuchi, Pharmaceutical Research, Chugai Pharmaceutical Co Ltd.

Esther M. Yoo, Ph.D., Postdoctoral Fellow, University of California, Department of Microbiology, Immunology and Molecular Genetics

Haruki Hasegawa, Ph.D., Cell Biologist, Protein Science, Amgen, Inc.


SC9: Introduction to the Baculovirus Expression System – History and Recent Advances
This short course will provide an overview of the baculovirus expression platform from its initial development to its current status. Examples of its current utilization will be presented.

What You Will Learn:
• Basics of the Technology: Cell lines, vectors, media
• Optimization of Expression
• Limitations of the platform
• Future Prospects

This course is primarily intended for novice users and those unfamiliar with the system.

Instructor: James M. Groarke, Biortus Biosciences


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