Analytical Data Analysis for the Bioprocessing Industry
Understand how to manage analytical data and its relevance on the process and product.
29 April - 2 May 2018
The module explores risk based decision making for bioprocess analytics by considering why a measurement is being made and what it conveys with regard to product critical quality attributes.
Expert lectures supported by a series of workshops and case studies will enable you to:
- Gain deeper understanding of how and why measurements are made.
- Use statistical methods to assess the validity of data and its impact on critical product quality attributes.
- Empower you to make a greater impact in the practical aspects and to be a more effective member of an interdisciplinary development or manufacturing team.
- Explore best practice in team working exercises and in numerical analysis of case studies
- Network with sector leaders and subject matter experts.
Who should attend?
This course is intended for engineers and scientists who are involved in the generation and use of analytical data for bioprocesses. Each concept and topic covered will be explained in detail and an example case study is then used to develop delegates’ understanding and help place the topics in context.
Typically, delegates are: R&D scientists, engineers or managers who wish to learn more about the analytics lifecycle and be more actively involved in creating understanding from analytical data. Analytical Data Analysis for the Bioprocessing Industry.
Overview of analytics lifecycle – why are we doing the measurements
• Analytical challenges in the manufacture of biologics
• Workshop: Experiences of analytics
• Rationalising the analytical testing toolbox
• Measurement of cell therapy potency – an analytical challenge
Is my measurement valid?
• Workshop: Statistical approaches to data analysis (computer based laboratory session)
• Case study: Specification limit setting
• Analytical comparability to support manufacturing changes
during the product lifecycle
• Expectations of regulatory agencies for analytical requirements
in development of biological medicinal products
Practical application of analytical technologies to the product development lifecycle
• How do I measure and why
• The evolution of analytical methods during the process lifecycle
• Case Study: Selecting methods for a biopharmaceutical specification
• Biosimilars: the analytical specification challenge
• Safety and Efficacy: the evolution of vaccine testing
Analytics to support manufacturing
• Case Study: Managing planned and unplanned process deviations
• The future analytical needs of the burgeoning biologics sector
Dr Farlan Veraitch, University College London
Mike Davies, F-star
Previous Expert Speakers Include
Liam O’Hare, Consultant
Richard Alldread, CPI
Viv Lindo, MedImmune
Mike Molloy, GSK
Assa Oumie, Cell and Gene Therapy Catapult
Gerard Powell, Allergan
Richard Turner, Clinical Network Services
Clemens Stilling, UCB
A social networking event will be held for delegates and speakers
For further information and bookings please contact:
T: +44 (0) 20 7679 9619 I +44 (0) 203 549 5619