Mark Van Ooij | Scientific Director, Per.C6 Technical Lead And Head Of Platform Innovation And Implementation
Janssen
I performed my PhD studies at the University in Nijmegen, the Netherlands, within the Virology department. During my PhD I worked on picornaviruses to study the presence of RNA elements essential for virus replication. Obtained PhD degree in 2007. In 2005 I started working at Crucell (Currently Janssen Vaccines) at the Molecular Virology department and worked on the introduction of molecular biological techniques as release tests.
I expanded my scope in the following year to cell based methods and biochemical methods with focus on content, potency and purity methods for vaccines. Responsibilities were expanded to contamination testing, and risk management, focusing on TSE/BSE, virus safety and extraneous agents related analytical detection techniques and involved in setting up analytical strategies for release and stability testing of recombinant viral vaccines. Assumed content responsibility of the PER.C6 cell line management with licensees.
As of 2016, USP Viral Vaccine expert panel member. Within the VPAD organisatio moved from Analytical Development to Drug Substance Development in 2018 and became “Head of Platform Innovation and Implementation” to prepare strategic topics for discussion with Health Agencies Scientific Advice meetings. Focus is on PER.C6 management, Advac/ PER.C6 platform management and OMCL/ National Control Lab management for Janssens Vaccine Lot release.
Appearances:
Pre-congress Workshops, April 6 @ 10:00
WORKSHOP G (FULL DAY): ANALYTICAL METHODS TO SUPPORT VACCINE QUALITY
Analytical methods that ensure identity, purity, and potency of vaccines have continued to improve but are primarily used for characterization rather than release testing. USP Biologics will gather stakeholders to learn about novel methods and to discuss opportunities to advance these methods in both pharmaceutical QClabs as well as global control laboratories. The workshop will include talks as well as an expert panel to debate these topics and address questions from the audience.Workshop leader opening remarks: Dr Maura C. Kibbey, Senior Scientific Fellow, Education & Training, Global Biologics, USPPresenations topics include:- Use of NMR assays for characterization of polysaccharide-based vaccines
- Opportunities and challenges of in vitro potency development for FSME Immun release and stability testing
- A regulatory perspective on NGS for adventitious virus detection in biologics
- Strategies and Examples for vaccine development and lifecycle management
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