The Accelerating Biopharmaceutical Program is organized as a single-session, Gordon-style conference, consisting of the following eight sessions. Submit an Abstract.

1.  Setting the Conference Context and Drivers

2.  Rapid Cell Line Development and Improved Expression System Development
The session will highlight advances in expression systems and cell line development that address key drivers in the field:  the need for rapid entry of new product candidates into the clinic and for highly efficient processes that maximize facility utilization and minimize costs of protein manufacture.  This session also includes approaches for streamlining upstream process development.

3. Rapid and Economic Purification Process Development
This session addresses approaches to optimize the speed, efficiency, and cost of purification process development and manufacturing.

4.   Cutting-Edge Analytical Techniques
This session covers applications of the latest analytical technology to support product development, including high-throughput and robotic techniques, mass spectrometry, and UPLC.

5.   High Throughput Protein Formulation Development
This session includes presentations on both potential applications as well as case studies of high throughput methodologies for formulation development of biopharmaceutical drugs, including quality by design strategies, robotics, rapid analyses and data processing and visualization methods.

6.  Emerging, “Disruptive” Technologies
This session will review the promise and pitfalls of exploratory process and production technologies, through consideration of technical risks, scale-up potential, impact on process economics and implications for facility design. Advances in protein engineering, novel expression systems, unique molecular platforms and process technologies as well as other topics that could dramatically impact biopharmaceutical development over the next 10 years will be covered.

7.  Critical Quality Attributes, Specifications and Comparability.  
Phase-Appropriate Process Development Strategies and Regulatory Expectations.

8.  Functional Interaction, Integration, and Synergy in Platform Development – from Amino Acid Sequence Identification to Protein Delivery
Where can we have the most impact in the Development paradigm?   What are the leverage points?  What are the points of greatest potential synergy between functional areas?  How do we triangulate the issues of speed, cost and product quality during development?  How do the decisions we make pre-licensure impact out ability to improve the process post-licensure? 

You can submit an abstract here.