Biopharmaceutical Development and Production Week November 2010

BPI Contributor

November 1, 2010

3 Min Read



Join us for the week and you will

  • Examine the latest scientific and technical advances to overcome the critical challenges faced by bioprocessing professionals at all stages of development to help you achieve your company’s process and product development goals.

  • Find solutions to the unique challenges of developing and manufacturing therapeutic proteins, that will help you reduce time, cost, and variability during process and product development.

  • Learn approaches to implement the latest analytical technologies that optimize process and product development.

  • Find the ideal balance between in- and outsourcing to optimize your company’s core competencies, mitigate risk, and maximize productivity.

  • Hear case studies of novel process and analytical method transfers to increase efficiency while ensuring quality consistency.

  • Learn how companies are interpreting the process validation guidance and hear strategies for conducting process and analytical validation.

Discussion forums will provide uncensored insights on some of the industry’s most pressing concerns: What are we doing with our idle capacity? Can we create a consortium for small and large companies to deal with overcapacity as a community? What are phase-appropriate approaches to support exploratory investigational new drug (IND) applications? Keynote Presentations

“OBP’s Pilot Program for QbD: Initial Results and Next Steps” by Patrick Swann (deputy director of the division of monoclonal antibodies at FDA/CDER’s Office of Biotechnology Products)

“Risk-based Approaches to Process Understanding and Manufacturing Control” by Mansoor A. Khan (director of the division of product quality research at FDA/CDER/OPS/OTR)

“Generation and Characterization of Novel Mono- or Multi-Specific Therapeutic Proteins for Oncology and Autoimmune Diseases” by Kendall Mohler (senior vice president of research and development at Trubion)

“Process Validation Moves Forward: A Global Evolution of Quality Improvement with QbD” by Donald Singer of GlaxoSmithKline (and national director of the American Society for Quality)

“Closer Quality Relations: Meeting Agency Expectations for CMO Oversight” by Sarah Thomas (vice president of quality for Human Genome Sciences)

“Defining and Demonstrating Suitable Product Quality Over the Course of Development” by Reed Harris (senior director of protein analytical chemistry at Genentech, Inc.) Six Conferences, One Location

Process and Product Validation (14–15 March 2011): Incorporating the new process validation guidance to ensure product quality while maximizing productivity

Technology Transfer for Biopharmaceuticals (14–15 March 2011): Ensuring process and analytical transfer success with greater process understanding, risk management, and control

Outsourcing Manufacturing of Biopharmaceuticals (14–15 March 2011): Optimizing your core competencies while managing a healthy CMO partnership

Antibody Development and Production (16–18 March 2011): Combining technical and scientific innovations with industry collaboration to overcome bioprocessing challenges

Recombinant Protein and Complex Biologic Development and Production (16–18 March 2011): Approaches to overcome the unique technical and scientific challenges of developing novel molecules

Analytical Technologies for Biotherapeutic Development (16–18 March 2011): Implementing novel analytical approaches and technologies from early to late stage

IBC has designed two-, three-, and five-day conferences package options to accommodate all your needs. Early registration is encouraged to take advantage of preregistration discounts. Group discounts are available to groups of three or more. Complete details can be found on the website, or call 1-800-309-4078. When registering, mention priority code BPIFEBDP. What Attendees Say…

“A fluid representation of the changing landscape of our industry, allowing networking and topical discussion around our industry’s current state of the art and the relevant challenges of the day.” — B.D. Monroe (Life Technologies)

“Good topics, good people, discussions on the point!” — J. Friedle (Atoll GmbH)

“Speakers were very open to sharing ideas and lessons learned from real-world projects. The information discussed was quite relevant to my own work.” — M. Pujols (MedImmune, LLC)

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