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THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

Track Overviews

Track Overviews

Keynote Speakers

David J. Pollard, Ph.D.

Innovating Antibody Production to Support the Immunotherapy Revolution
David J. Pollard, Ph.D.
Executive Director, BioProcess Development
Merck & Co. Inc

Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics
Spencer Fisk
Global Head, Biologics Process Research and Development
Novartis, Switzerland

Cell Culture & Upstream Processing Track Value:

Process development scientists, engineers and technical experts share their recent achievements in reducing timelines and COGs while increasing efficiency and productivity through implementation of disruptive approaches and technologies across all stages of cell culture.

Cell Culture & Upstream Processing Track Coverage:

  • Cell line development and engineering
  • Implementation of genome editing tools
  • Improving and controlling process and product quality
  • Impact of cell culture on critical quality attributes
  • Media Development & Optimization
  • Raw material sourcing, management and integrity
  • Developing processes for emerging modalities
  • Commercial single-use applications in upstream processing
  • Implementation of continuous processing
  • Impact of process intensification on Development

» Submit a speaking proposal

Recovery & Purification Track Value:

Building on the momentum being gained from the innovation of methodologies, materials science and technologies, companies will describe progress being made to optimize efficiencies, process design and flexibility in downstream processing for an emerging wave of antibodies and novel modalities.

Recovery & Purification Track Coverage:

  • Impact of new technologies on harvest step
  • Approaches to improve efficiencies and cost of goods while reduce timelines
  • Implementation of automated and high throughput process development
  • Utilizing clinical and commercial single-use systems in downstream processing
  • Advances in modeling and characterization to better predict, understand and control processes
  • Development and implementation of continuous downstream processes
  • Purification approaches and platforms for novel modalities
  • Impact on novel purification methods on downstream processing

» Submit a speaking proposal

Manufacturing Strategy Track Value:

Biomanufacturing experts share strategies to maximize efficiencies and cost savings across your manufacturing network through implementation of disruptive technologies, operational excellence and new facility concepts. Learn how to develop your manufacturing infrastructure so you can remain flexible to the production needs of a diverse pipeline of novel biologic molecules in a multiproduct environment.

Manufacturing Strategy Track Coverage:

  • Operational efficiency, facility optimization, process economics and manufacturing portfolio planning
  • Manufacturing technologies and case studies to increase efficiency in clinical or commercial production
  • Single-use technology implementation case studies (clinical and commercial)
  • Biomanufacturing of emerging modalities and complex molecules
  • Continuous processing and continuous biomanufacturing

» Submit a speaking proposal

Analytical, Formulation and Quality Track Value:

Thought-leaders in the field help you to stay abreast of emerging analytical tools and formulation strategies for mAb, non-mAb and next generation biotherapeutics. Learn about the impact of increasing quality expectations for your products and processes so you can optimize your analytical and formulation strategy and reduce quality risk across the product lifecycle.

Analytical, Formulation and Quality Track Coverage:

  • Analytical & formulation strategies to improve quality attributes & stability of molecules
  • High-throughput analytical methods for rapid process development
  • Analytical control strategies to ensure product quality
  • Phase-appropriate Formulation Strategies
  • Stability and Physiochemical Characterization
  • Phase appropriate control strategies for biologics: setting specifications, CMC strategies and QC stability
  • Quality manufacturing & QbD: risk assessment, quality auditing and product lifecycle planning
  • Technical quality aspects of process development and manufacturing
  • Implementation of analytics for advanced monitoring and adaptive controls

» Submit a speaking proposal

Drug Product Manufacturing & Fill-Finish Processing Track Value:

Explore the technologies, strategies and solutions involved in moving from API (drug substance) to finished drug product ready for human use. Case studies and real world experiences will be presented to highlight potential pitfalls and challenges for a variety of different products. An evaluation of emerging technologies and creative drug product solutions will also be presented.

Drug Product Manufacturing & Fill-Finish Processing Track Coverage:

  • Moving from drug substance to fill/finish
  • Container closure integrity testing and technology
  • Lyophilization challenges and strategies
  • Isolator technology integration with other technologies
  • Fill-finish challenges for high viscosity/high concentration molecules
  • Visual inspections and particulates
  • Stopper, vial and device quality
  • Delivery of drug substance: the interface between drug substance delivery and drug product

» Submit a speaking proposal

Early Stage Biologics and Early Stage Companies Track Value:

Learn how to accelerate the transition from biologics discovery to IND and beyond by implementing these key strategies and critical development activities. Learn from experts who will help guide you through the steps you need to take to help you reduce your risk, development timeline and costs, while maximizing the chance of success for your new products.

Early Stage Biologics and Early Stage Companies Track Coverage:

  • Strategies to move quickly to IND and beyond
  • Getting more done with less
  • Maximizing value across the biologics lifecycle
  • Case studies of rapid biologics development
  • Identifying critical early development activities from discovery to first-in-human

» Submit a speaking proposal

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