How to Maximize Virus Safety at Minimized Cost: Case Studies
Many biopharmaceutical therapies, such as mAbs and blood plasma factors, are produced using biological materials. This carries the risk that microorganisms such as viral contaminants may be unintentionally introduced into the manufacturing process and contaminate the product. Thus of paramount importance is the removal of such adventitious agents using effective viral filtration methods.
In this webinar, the fundamental principles of virus filtration as well as its practical execution will be discussed. In addition, participants will gain an in-depth understanding of filterability, validation and the local regulatory framework surrounding virus filtration processes. By the conclusion of the session, all attendees should be able to conduct a virus filterability trial and will be well equipped to have appropriate discussions with validation labs.
Participants will learn:
- Regulatory framework
- Principles of virus filtration
- How to maximize virus safety at minimized cost
- How to validate continuous viral clearance process
Morven McAlister, Ph.D.
Global Sr. Director, Regulatory and Validation Consultancy
Dr Morven McAlister is the Global Senior Director of the Regulatory and Validation Consultancy team at Pall Biotech. She is currently involved in using Quality by Design (QbD) principles for new process applications, product, and method development, as well as supporting microbial risk mitigation practices for end-users. She is also actively involved in various industry task forces (e.g. BPOG, PDA, ASTM) to standardize methods and technical positioning around microbial contamination control.
Nigel B. Jackson
Principal Engineer R&D
Since his PhD in Biochemical Engineering, Nigel Jackson has over 10 years of experience in Biotech Process R&D within Pall Biotech. Nigel has multiple publications and conference presentations demonstrating a deep understanding of virus filtration and general bioprocessing. He has directed this knowledge into helping Pall develop robust and effective new virus filters and many other Pall Biotech products and applications. He has also recently taken on the role of Visiting Lecturer at University College London.
Global Product Manager Virus Filtration
Aernout Martens holds a Master degree in Bioprocess Engineering and a PhD in Physical Chemistry. After his post-doc research on extracellular matric ligand interactions, he started working at Pall as a bio-purification specialist, after which he specialized in virus filtration and became global product manager for the Pall virus filter portfolio.
Principal Scientist, SLS – Global Regulatory and Validation Consulting Group
Sudhakar Nagaraj has been in Pharmaceutical industry for over 18 years and has held positions of increasing responsibility in Pharmaceutical QC/QA, R&D, Validations and Regulatory affairs. He joined Pall during 2006 in Scientific Laboratory Services (SLS) organization and has been involved in updating Pall’s technical support portfolios with rapidly evolving end-user and regulatory requirements, to streamline customer selection, adoption and successful regulatory approval of Pall technologies.