Disposable Solutions for Biomanufacturing Online 2011 schedule

Tuesday 6th September 2011

• Driving Innovation in the Bioprocessing Industry

  by Mark Bustard

  • Furthering development through building communities and enhancing communication
  • Facilitating knowledge transfer by setting up partnerships between academia and pharma
  • Using single use technology to build capacity

  Speaker:
  Dr Mark Bustard, Head of Bioprocessing, HealthTech and Medicines KTN

  At 2:00pm to 2:00pm, Tuesday 6th September

• CASE STUDY: Setting Up a Fully Disposable Plant: The Good, the Bad and the Ugly

  by Gary Lye

  • Applying academic research to help underpin disposables-based bioprocess development and manufacture
  • How can academia and industry best collaborate to deliver these future research and training needs?
  • CASE STUDY: addressing these points with examples of disposables-based research and training activities underway in the new Responsive Bioprocessing Facility at UCL

  Speaker:
  Gary Lye, Deputy Head Department Bioengineering, University College London

  At 3:00pm to 3:00pm, Tuesday 6th September

Thursday 8th September 2011

• CASE STUDY: The Regulatory View on Disposable Biomanufacturing, Submission Criteria and Approval Processes

  by MHRA

  • Understanding the approval process for biologics and the manufacturing considerations
  • Our expectations for submission criteria for disposable manufacturing processes
  • Working examples of good and bad practice: overcoming the challenges

  Speaker:
  to be confirmed, MHRA

  At 2:00pm to 2:00pm, Thursday 8th September

• Establishing Best Practice Approaches to Implement Health and Safety Parameters

  by Tony Hitchcock

  • Potential health and safety risks associated with disposable systems
  • Assessing the next steps for standardisation of procedures
  • How do we establish best practice?
  • Discussion: Differences between health and safety expectations globally

  Speaker:
  Tony Hitchcock, Head of Manufacturing Technologies, Recipharm Cobra

  At 3:00pm to 3:00pm, Thursday 8th September

Tuesday 13th September 2011

• Saving Time and Cost through Developing a Risk Based System to Extractable and Leachable Testing

  by Ingrid Markovic

  • Prioritising your extractable and leachable tests
  • Designing and implementing a risk based testing approach
  • Understanding the regualtory expectations and submission criteria

  Speaker:
  Dr. Ingrid Markovic, Expert Review Scientist, CDER, FDA

  At 2:00pm to 2:00pm, Tuesday 13th September

• Leachables and Particulates in Biopharmaceuticals – Why are These Suddenly an Issue for Biotech?

  by Nadine Ritter

  • An overview of the growing biotech industry globally
  • Investigating the increasing trend towards biosimilar development in Asia
  • Understanding the impact of leachables and particulates on product safety
  • Designing a comprehensive testing programme to ensure patient safety and regulatory compliance

  Speaker:
  Nadine Ritter, Biologics Consulting Group, Senior CMC Consultant

  At 3:00pm to 3:00pm, Tuesday 13th September

Thursday 15th September 2011

• CASE STUDY: Comparing and Contrasting Bioreactors – are they Suitable for Large Scale Use?

  by Aurore Poles

  • Part two of our comparative study - rational, challenges and results
  • Predicting and overcoming quality concerns
  • Assessing the right bioreactors for your facility and steps for successful integration

  Speaker:
  Aurore Poles, Specialist New Technologies and Manufacturing Support , Merck Serono

  At 2:00pm to 2:00pm, Thursday 15th September

Tuesday 20th September 2011

• Implementing Single Use Systems and an Effective Supplier Qualification Process

  by Stephen Brown

  • Risk-based implementation of single use systems
  • Developing an effective implementation plan
  • Best practice for stakeholder management
  • Taking a risk management focused approach
  • Process validation and life-cycle concept
  • Optimising materials management, testing adn timelines and supplier qualification
  • Fully understanding the supplier (sourcing, capacity, contracts)
  • Manufacture and testing of SUS
  • Designing and implementing quality systems - quality and technical agreements, change control and auditing

  Speaker:
  Stephen Brown, CTO, Vivalis

  At 2:00pm to 2:00pm, Tuesday 20th September

• PANEL: Addressing Compatibility Issues between Suppliers – will we ever see harmonisation?

  by Aurore Poles, Stephen Brown and Jerold Martin

  This panel will address the challenges of integration between different vendors and how to asses compatibility. Flexibility and the ability to work with multiple suppliers is a crucial factor in the decision to switch to single use and how and when to implement. Take the chance to discuss with end users and vendors alike as to how they are planning to achieve harmonisation...

  Panelists:
  Aurore Poles, Specialist New Technologies and Manufacturing Support, , Merck Serono
  Stephen Brown, CTO, Vivalis
  Jerold Martin, Chairman of the Board, BPSA

  At 3:00pm to 3:00pm, Tuesday 20th September

Thursday 22nd September 2011

• CASE STUDY: Achieving Operational Excellence

  by Alain Pralong

  • Is operational excellence applicable to process development of biopharmaceuticals?
  • Does the biopharmaceutical environment simplify operational excellence?
  • Is operational excellence enough as a focus for the future?

  Speaker:
  Alain Pralong, VP Process Development, Crucel

  At 2:00pm to 2:00pm, Thursday 22nd September

• How Suppliers Can Help Users Meet GMP

  by Jerold Martin

  • Understanding what suppliers can do for process design, extractables, particulates, endotoxins, integrity
  • Working with your supplier to ensure compliance
  • Addressing quality/regulatory concerns
  • This session will also include comments and updates from the PDA SUS Workshop and BPSA Int'l SU Summit

  Speaker:
  Jerold Martin, Chairman of the Board, BPSA

  At 3:00pm to 3:00pm, Thursday 22nd September

Thursday 29th September 2011

• CASE STUDY: Our Experience with Implementing Single Use Systems on a Global Scale

  by Kit Erlebach

  Speaker:
  Kit Erlebach, Head of Technical Operations, MSD Biologics

  At 2:00pm to 2:00pm, Thursday 29th September

• PANEL: Assessing the Future of Single Use Systems and Moving Towards 100% Disposable Facilities on a Global Scale

  by Morten Munk and Rene Brecht

  This interactive session will allow you to explore the future of the industry adn how to take the next steps towards implementing disposable biomnaufacturing systems on a global and commercial scale. What is the goal for your facility and what is your strategy to get there?

  Panelists:
  Rene Brecht, VP Process Science and Manufacturing, ProBioGen
  Morten Munk, VP / Co-Chair, Single-Use Systems Task Force, CMC Bio / PDA

  At 3:00pm to 3:00pm, Thursday 29th September