Conference Day One: Tuesday 25 May 2010

08.00 Coffee And Registration

08.50 Pharma IQ Welcome And Chairperson’s Opening Remarks

REDUCING DEVELOPMENT RISK AND ENHANCING MANUFACTURE THROUGH QUALITY BY DESIGN

09.00 Case Study: Applying Enhanced Quality By Design Approaches For The Manufacture Of A Mammalian Cell-Derived Recombinant Protein

  • Describing the current Merck-Serono approach to the development and validation of drug substance manufacturing processes for NBE’s
  • Illustrating some of the principles outlined in ICH Q8/Q9/Q10 with a "real-life" case study
  • Discussion of the practical approaches for the exploitation of prior process knowledge accumulated during development and the characterisation of individual process steps such as:
    • The application of QRM principles for the definition of potential critical process parameters (pCPP)
    • The systematic characterisation of each unit operation from cell culture through purification steps
    • The use of multivariate designs of experiments performed on qualified scale-down models
  • Addressing some of the challenges encountered during the definition of a global process design space and the resulting process validation studies

Pascal Valax
Group Manager, Biotech Process Sciences, Downstream Processing
Merck Serono S.A

09.45 Case Study: In Silico Methods To Reduce Development Risks In Biotherapeutics: Selecting And Engineering Optimal Lead Compounds

  • Aggregation and stability issues and impact in process development and safety.
  • Opportunities for designing quality in the product & expand the DSP design space
  • Risk assessment in lead selection. In silico predictors for selection of optimal leads.
  • Engineering biopharmaceuticals for improved developability

Dr Jesus Zurdo
Head of Advanced Protein Technologies
Lonza Biologics UK

10.30 Networking Coffee Break

ENHANCING PROCESS DEVELOPMENT AND MANUFACTURE THROUGH RETROSPECTIVE QUALITY BY DESIGN AND ADOPTING SINGLE-USE SYSTEMS

11.00 Case Study: The Impact Of Single-Use Technologies On Biopharmaceutical Process Development And Manufacture

  • Discussion of the prime applications available for large molecule studies within the single-use field
  • How can the application of this technology benefit understanding and control of the end product efficacy, quality and production process?
  • Incorporating single-use systems into your overall quality by design strategy

Dr Jens Gram
Director, Project Science
CMC Biologics A/S

11.45 Case Study: Why Perform Retrospective QbD Analyses With Biotech Products?

  • How to establish where to focus on and how much
  • Understanding the limitations of process type
  • Discussion of practical applications

Tim Clayton
Manufacturing Technical Services Director
Merck Serono S.A

12.30 Technology Spotlight

This session will be dedicated to a leading service provider from within the PAT and QbD arena, offering you the opportunity to hear first-hand how the latest technology innovations could help you reach your PAT and QbD application goals.

13.00 Networking Lunch Break

ESTABLISHING A MORE EFFECTIVE RISK ASSESSMENT AND VALIDATION STRATEGY WHEN APPLYING QUALITY BY DESIGN TECHNIQUES

14.30 Role Of Risk Assessment And Management In Implementation Of Quality By Design (QbD)

This talk will focus on some of the use of various risk assessment and management tools in performing key activities that are necessary for successful implementation of QbD. These activities include:

  • Assessment of criticality of product quality attributes
  • Prioritisation of process parameters for process characterisation and validation
  • Estimation of process capability
  • Evaluation of criticality of raw materials

Professor Anurag Rathore
Department of Chemical Engineering
Indian Institute of Technology

15.15 Case Study: Implementation Of QbD Aproaches In A Strategy For Process Validation

  • The importance of a structured approach to Design of Experiment studies
  • Techniques for gaining process understanding in order to derisk process validation
  • Coping with change during process characterisation and technology transfer
  • The value of risk assessments and where they can be applied

Dr Simon Hanslip
Technical Project Leader
Avecia

16.00 Break-Out Round Table Discussions:

Participants will be able to choose between the different roundtables and spend 60 minutes discussing the points outlined below before feeding back to the delegation

Roundtable A

How to Effectively Determine CQA’s for Large Molecules Products

Facilitator:

Dr Stephan Ward
Director of Development
Stabilitech

Roundtable B

Designing your Design Space for Biopharmaceutical Products

Facilitator:

Amit Banerjee
Research Fellow, Purification
Pfizer USA.

Roundtable C

Successfully Applying Risk Management Techniques To Support your Quality by Design Initiatives

Facilitator:

Dr Simon Hanslip
Technical Project Leader
Avecia

17.00 Chairpersons Closing Remarks And Close Of Day One

17.10 Networking Coffee

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