SUBMIT PROPOSAL

If you are working in any of the following scientific/business topic areas, we encourage you to submit a proposal for a podium presentation. We are especially looking for case studies with new data on the following:

Track: Manufacturing Strategy

  • Manufacturing Optimization and Process Intensification to Lower Cost of Goods
  • Examples of Reducing Cost and Increasing Efficiencies in Biologics Manufacturing
  • Setting Up Biologics Manufacturing Capability with Limited Resources
  • Continuous Manufacturing Implementation
  • Manufacturing Case Studies for Non-Antibodies and Complex Molecules
  • “Smart Factories” of the Future and Flexible Manufacturing
  • Manufacturing Vaccines and Biologics with Single-Use Technologies
  • Lessons Learned from Recent Regulatory Submissions
  • Improving Efficiencies of Aging Biologics Facilities: Adapting Capacity and Capabilities
  • Manufacturing for Late Stage Development and Commercial Products
  • Controlling Raw Material Variability to Improve Product Yield, Quality and Consistency
  • Advanced Process Controls, PAT, Real-Time/At-Line Analytics and Predictive Modeling
  • Post-Approval Manufacturing Changes, Strategies and Experiences
  • Commercial Lifecycle Management, Demand Modeling and Decision Making

Track: Cell Culture & Upstream Processing

  • Addressing Cell Line Development Needs with New Technologies and Strategies
  • Expectations for Targeted Integration
  • Integration of Automation into Cell Line and Cell Culture Development
  • Gene Editing Tools and Approaches
  • Progress and Benefits of Using Alternative Expression Systems
  • Expression Challenges of Engineered Products
  • Emerging Analytical Technologies and Strategies for Process Control and PQAs
  • Process Optimization and Acceleration Strategies
  • Approaches for Process Intensification
  • Innovations Leading to Improved Speed and Efficiency
  • Progress Towards Fully-Integrated Continuous Processing
  • Process Scale Up/Down and Characterization
  • Addressing Challenges for Developing Non-mAbs and Emerging Modalities
  • Next Gen Sequencing

Track: Recovery & Purification

  • Continuous Viral Inactivation
  • Integration of Automation in Downstream Processing
  • PAT for Process Development
  • High Throughput Process Analytics
  • Progress Towards Fully-Integrated Continuous Processing
  • Smart Polymers in Flocculation Process
  • Novel Materials and Novel Bioprocessing Approaches
  • Purification Challenges for Novel Modalities
  • Approaches to Streamline Process Characterization and Validation
  • Process Optimization and Acceleration Strategies
  • Innovations Leading to Improved Speed and Efficiency
  • Viral Safety

Track: Speed from Gene to Market

  • Speed to IND
  • The Downside of Speed to IND – Risks and Impact on Later Development
  • Overcoming the Lag in Analytical – Approaches in Analytical Sciences that Enable Speed
  • The Cost of Speed – How Preclinical Shortcuts Impact Molecule Value and Tech Transfer
  • Regulatory and Quality Challenges in Accelerating Timelines
  • Challenges and Risks of Accelerating Non-mAbs and Emerging Modalities
  • Speed to BLA
  • Single Cycle Development

Track: Drug Product, Fill-Finish & Formulations

  • Drug Product Predictive Modeling and Simulations
  • Technical Challenges and Strategies Moving from Drug Substance to Fill-Finish
  • Case Studies of Process Improvements in Formulations and Fill-Finish
  • Lessons Learned from Recent Regulatory Submissions
  • Drug Product Process Characterization and Process Validation
  • Pre-filled Syringes and Devices: Drug Product Strategies
  • Supply Chain Strategies for Fill-Finish
  • Lyophilization Strategies & Scale-up
  • Novel and Adaptive Drug Product-Fill Finish Technologies
  • Drug Product PAT Strategies
  • Strategies for Filter-Flush or Visual Inspections
  • Applications of Single use in Fill-Finish
  • Extractables, Leachables, Particulates and Container-Closure
  • Strategies for High Protein Concentration Formulations or Pediatric Formulations
  • Formulation Strategies to Improve Quality Attributes & Stability of Molecules
  • Formulation Case Studies for Complex Biologics

Track: Analytical & Quality

  • Method Lifecycle Management and Validation for CMC: Developing Platform Methods
  • Analytical Control Strategies and Analytics to Support QbD
  • High-throughput Analytics, Automation and Predictive Tools for Complex Molecules
  • Analytical Strategies for Biosimilars
  • Analytical Strategies for Combination Products & Co-Formulations
  • CMC Strategies for Different Biologic Modalities and Non-Antibodies
  • Process Characterization and Process Validation
  • Advanced Analytics and Predictive Models for Continuous Process Verification -CPV
  • Lessons Learned from Recent Regulatory Submissions
  • Phase Appropriate Control Strategies: Setting Specifications, CMC and QC Stability
  • Analytical Characterization Strategies for Complex Biologics
  • Quality Risk Assessment in Facilities, Equipment, Utilities and Programs
  • Quality System Metrics and Quality Assurance throughout the Product Lifecycle
  • Quality Considerations for Tech Transfer, Inspection Preparation and Change Management
  • Extractables, Leachables, Particulates and Container-Closure
  • Technical Quality Aspects of Process Development and Manufacturing

Track: Bioprocessing 4.0 - The Path to Smart Manufacturing

  • Implementation of Automation across the Process Development and Manufacturing Lifecycle
  • Application of PAT or Advanced/Real-Time Process Controls with Online Multivariate Analysis
  • Disruptive Technologies, Emerging Platforms and New Models for Bioprocessing and Factories of the Future
  • Big Data and Data Mining: Techniques for Analyzing and Modeling Data in Bioprocessing
  • Digital Biomanufacturing and Artificial Intelligence Applied to Biomanufacturing
  • Modernizing Biologics Manufacturing: What Can We Learn from Other Industries?

Submit a Proposal

Poster Hall Hours

Tuesday, May 10, 2016
3:00 pm - 6:30 pm

Wednesday, May 11, 2016
10:00 am - 6:30 pm

Thursday, May 12, 2016
10:30 am - 2:00 pm

Presentations should be free of commercial bias as well as any references to commercial products and services. All selected faculty are required to disclose the existence of any significant financial interest. Financial interest may affect the consideration of your presentation/proposal application.

You will be notified by the Event Review Committee if your presentation has been selected.

Call for Speakers

The abstract submission deadline has been extended to Friday, March 16, 2018

September 4-7, 2018
Hynes Convention Center,
Boston, MA

BioProcess International Conference & Exhibition

September 4-7, 2018
Hynes Convention Center,
Boston, MA

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