How to identify and manage sources of bioprocess variation for greater product consistency
Biopharmaceutical manufacturing processes are complex, challenging and utilize living organisms to produce safe and efficacious biopharmaceuticals. These molecules themselves have high molecular weights and complex structures that exhibit heterogeneity such that any given vial contains not one active ingredient but a population of biologically active molecules which must have maximal benefit to the patient with minimal deleterious effects. The necessity for controlling variation in processes and hence product is self-evident when we consider how our actions affect the lives of the patients our products are developed for.
This webinar will focus on understanding the various origins of process variation within a biopharmaceutical manufacturing process and examine strategies for either reducing their impact or eliminating them altogether. The use of Quality by Design and Process Analytical Technologies to achieve these aims will be described along with strategies for increasing process consistency through sensing and automation.
Attending audience members will learn to identify manufacturing variability that can contribute to product variability and how these types of variation have been successfully controlled through process development and in operations by the industry.
Register now to take control of variation in your bioprocess.
Presented by
Nick Hutchinson,
Market Development Manager
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focussed on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA.
Nick now works in Market Development at Parker domnick hunter where his focus is on bringing Parker's strengths in motion & control to bioprocessing in order to enable improvements in the quality and deliverability of existing and future biopharmaceuticals.
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Key Learning Objectives
- Understand the link between product and bioprocess variation.
- Understand sources of bioprocess variation.
- Understand how the industry has previously sought to minimize bioprocess variation by process development.
- Understand how the industry has previously sought to minimize bioprocess variation by operating practices.
Audience
- Cell Culture Development Scientists
- Purification Development Scientists
- Quality Assurance
- Automation Engineers
- Production Managers
- Manufacturing Science and Technology
