Recent, high-profile contamination events involving major biopharmaceutical manufacturers have exposed the potential flaws in adopting a passive approach to defending against microbial threats, which can result in contaminated drug batches, regulatory intervention and in extreme examples even lead to tumbling shareprices. Such contamination events cannot easily be detected or removed from a process once present. Therefore a multi-faceted preventitive approach in addition to a thorough understanding of the manufacturing process is required to reduce the level of risk to a minimum.
The risk posed by mycoplasma is discussed, together with how this may impact biopharmaceutical drug production processes. Current industry approaches to mycoplasma control will be described with particular emphasis on the Parenteral Drug Association’s Mycoplasma Task Force and the resulting guidance derived from their work.
The practical application of microbiological detection methods, filtration technologies and process control techniques will be considered. Specific focus will be given to process control and its direct impact upon filter performance, relating to retention studies performed on a known mycoplasma contaminant organism.
Register now for this webinar to understand the risks posed by advantitious microorganisms and learn practical strategies for implementation of control techniques to provide a robust approach to preventing contamination events in your bioprocess.
Andy Kelly,
Product Manager (Life Science)
Andy Kelly works for Parker domnick hunter as Product Manager for the portfolio of pharmaceutical and life science filtration products, focussing on linking external commercial and marketing demands with the activities of both the engineering and operations business functions. Andy has previously held Research Scientist and Technical Support Scientist roles within the Parker domnick hunter organisation. Andy has a Bachelor’s degree with honours in Medical Microbiology from Newcastle University.
Dr Nick Hutchinson,
Global Market Development Manager
Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused 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 in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable our customers to improve the quality and deliverability of existing and future biopharmaceuticals.
- Understand the potential threat of Mycoplasma
- Understand the guidance from industry bodies
- Understand how detection, filtration and process control technology can prevent contamination
- Understand how to apply these technologies to a biopharmaceutical manufacturing process
- Cell Culture Scientists
- Upstream Process Development
- Quality Assurance
- Operations Managers
- Manufacturing Science and Technology
- Compliance
- Automation Engineers
