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Biopharmaceutical Development & Production Week

CSS

Innovation and Adoption of New Methods and Technologies for Emerging Biologics and Facilities of the Future

850+ Attendees · 175 Speakers · 60+ Exhibitors · 80+ Posters

March 30 - April 02, 2015 · Hyatt Regency Huntington Beach Resort & Spa · Huntington Beach, CA

Speaking Opportunities

Speaking Opportunities

We need your help. IBC Life Sciences is currently developing the agenda for Biopharmaceutical Development & Production (BDP) Week, which takes place March 30-April 2, 2015, at Hyatt Regency Huntington Beach Spa & Resort in Huntington Beach, CA

BDP Week 2015 will be the most in-depth and comprehensive concept-to-commercialization experience for professionals dedicated to the advancement of next-generation biologics via manufacturing facilities of the future. BDP Week will be even bigger in 2015, as for the first time, the event will also incorporate the expert content of IBC's Single-Use Applications and Flexible Facilities conferences.

Whether you are a research scientist or senior level executive, BDP Week is a must-attend gathering for collective discussion on challenges and insights on the ever-evolving biopharmaceutical development and production sector.

Take a greater role in this community, add to your professional accomplishments, and help shape the future of the field by presenting a talk at BDP Week.

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 We are especially looking for case studies with unpublished data on the following:

Manufacturing Efficiencies: Strategy & Technology

  • Strategic Outlooks for Manufacturing Capacity
  • Fully Integrated Continuous Processing
  • Economic Drivers for Continuous Biomanufacturing Processes
  • Utilizing Disposables in Continuous Processing
  • Approaches to Overcome Challenges of Tech Transfers to CMOs
  • Managing Supply Chain & Strategies for Primary Packaging and Shipping for Drug Product
  • Inspection and Enforcement Trends
  • Biomanufacturing of the Future
  • Strategies for Single Use Implementation

Upstream Processing

  • Cell Line Development & Engineering
  • Genome Editing Tools and Technologies
  • Modeling, Scale Up, Scale Down & Tech Transfers
  • Improving and Controlling Process and Product Quality
  • Impact of Cell Culture on Critical Quality Attributes
  • Media Development Optimization
  • Managing Raw Materials
  • Single Use Applications in Upstream Processing
  • Approaches to improve Efficiencies and Reduce Timelines from Discovery to Clinic to Commercial
  • Shifting Away from Traditional Platforms and Modalities
  • Continuous Upstream Processes

Downstream Processing

  • Advances for Harvest Step
  • Continuous Downstream Processes
  • Integrating Disposables (Clinical and Commercial) in Downstream Processing
  • Automated and High Throughput Process Development
  • Purification of Novel Molecules
  • Purifying Proteins from Alternative Expression Systems
  • Compression of Process Characterization
  • Approaches to improve Efficiencies and Reduce Timelines
  • Modeling, Scale Up and Scale Down
  • Challenges with High Concentration Drug Substance Drug Product Formulation

Antibody Drug Conjugate Development & Production

  • New Conjugation Methods and Technologies
  • Implementation of Disposables for Producing ADCs
  • Formulation Challenges for Next Generation ADCs
  • Challenges Associated to Implementing New Technologies
  • Managing Supply Chain
  • Early & Late Stage Process Development
  • Accelerating Times Lines in Process Development for Small and Large Molecules
  • Automation/High Throughput Process Development
  • Drug Linker Process Chemistry - From Bench to Commercialization
  • Critical Quality Attributes for ADCs
  • Analytical Development, Characterization & Comparability
  • Scale Up, Manufacturing & Outsourcing
  • Cleaning, Safety and Handling Issues and Guidelines

Engineering (Single-Use and Flexible Facilities)

  • Integrity Testing of Single-Use Assemblies
  • Single-Use vs. Tradition Reusable Probes
  • Batch versus Perfusion Mode
  • Extractables and Leachables and Particulate Control
  • Cell Culture Application Considerations
  • Continuous Processing and Closed Systems
  • Strategies for Single-Use Implementation
  • Process Development and Manufacturing Strategies
  • Flexible/Multiuse Facility Design Considerations
  • Cleaning and Monitoring Strategies for efficient changeover
  • Regulatory considerations for Flexible/Multiuse, and Facilities of the Future Engineering

Analytical

  • Breakthrough Status Designation Strategies and Considerations
  • Total Control Strategies for Host Cell Protein, Variant and Impurity Control
  • Extractables and Leachables Control for Product and Process
  • Comparability Strategies for Biosimilars and Other Biotechnology Products
  • Characterization and Control Host Cell Protein, Variants and Impurities
  • High-Throughput Analysis and Methods
  • Glycan Analysis Considerations
  • Aggregation and Subvisible Particle Characterization
  • High Concentration Proteins

Process Validation

  • Continuous manufacturing best practices
  • Regulatory considerations for new biotech manufacturing efforts
  • New approaches to implementing quality-by-design concepts in the commercial phase
  • Establishing reliable data with the latest process validation tools
  • Biosimilars development and production
  • Pros and cons of applying for FDA breakthrough therapy designation

Viral Safety

  • Next generation sequencing applications to detect novel viruses
  • Latest regulatory guidance to combat adventitious agents and novel viruses
  • Prioritizing contamination threats through forward-thinking risk assessments
  • High-temperature short-time (HTST) processing
  • Ultraviolet light in the C spectrum (UVC) treatment
  • Nano-filtration Concerns

Raw Materials and Supply Chain

  • Strategies for improved raw materials characterization
  • Tracing Raw Materials from their Origin
  • Monitoring Raw Materials in real Time with Data Tools
  • Anticipating and Mitigating New Scenarios for Supply Chain Disruptions
  • Control Strategies for Aging Cell Banks
  • Animal-Sourced Supplies as a Raw Material

Please use the form below to submit a presentation proposal. The deadline to submit a presentation is Monday, October 27, 2014.

If you would like to submit a proposal, but need an extension or have any topic suggestions, please contact Barry Walsh at 508-614-1464 or bwalsh@ibcusa.com, Mark DeSorbo at 508-614-1405 or mdesorbo@ibcusa.com, or Scott Wallask at 508-614-1208 or swallask@ibcusa.com.

If your talk is accepted, you will receive a formal invitation to speak at the conference. This invitation will reflect a deadline for you to send a final presentation title and 60-word abstract. Your abstract and presentation must describe scientific results and must not contain marketing or business development content.

Many thanks for your consideration of a role in the conference. Please write or call if I can answer any questions.

Best regards,

Barry Walsh
Conference Director
IBC Life Sciences
bwalsh@ibcusa.com
Tel: 508-614-1464

Corresponding Presenter
Affiliation
Mailing Address
Contact Information
Topic Area
Description of the Proposed Presentation's Content

Please keep "introductory" text on why your topic is important to an absolute minimum (one sentence maximum). Please elaborate on details of the type of case study data or experimental results you plan to give.

Note: Please spell out all Greek and special characters, e.g., microliter, alpha, etc.

Note: Please limit to a maximum of 150 words.

Description of the Intended Audience
Brief Biography
Send Proposal

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.

Fields in bold and green are required.

Environmental Monitoring & Contamination Control