Cell line characterization is key to ensuring the safety of biologics. Even with recent innovations in adventitious agent detection for cell banks, transmission electron microscopy (TEM) remains a cornerstone of these activities. This webinar will explore the capabilities of TEM for cell line characterization to understand why regulators still consider this assay to be a central component of the testing package.
The featured speakers will also examine how TEM contributes to a comprehensive safety profile when combined with complementary assays tailored to specific cell types, highlighting its strengths in detecting diverse adventitious agents and offering strategies to align with current regulatory expectations.
Register for this webinar to learn how TEM supports comprehensive cell line characterization strategies aligned with current regulatory expectations.
Speakers
Anna Woodward, PhD, Technical Consultant, MilliporeSigma
Anna Woodward joined MilliporeSigma in 2019 and has more than 15 years of experience providing technical support to developers and manufacturers of small molecules and biologics. In her current role as a Technical Consultant, Anna supports the BioReliance® services portfolio and works closely with clients and internal colleagues to provide scientific and regulatory guidance on biosafety testing packages. Anna holds a PhD in Cell Biology from the University of Dundee, Scotland.
Message Presenter
Gail Collinson, BSc (Hons), Senior Scientist, Cell Biology, MilliporeSigma
Gail Collinson joined the Cell Biology department in 2002 and has over 20 years’ experience performing transmission electron microscopy (TEM) work as both an Operator and a Study Director/Responsible Scientist. In her current role as a Senior Scientist, Gail supports all TEM assays within the BioReliance® services portfolio and ensures that TEM work is performed efficiently and safely. Gail holds an honours degree in Biomedical Sciences from Caledonian University, Glasgow, Scotland.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in:
- Process Development
- CMC Managers
- Quality Assurance
- Regulatory Affairs
- Quality Control Manager
- Biologics Safety Scientist
- Cell Line Development Scientist
- Analytical Development Scientist
- Product Development Scientist
What You Will Learn
Attendees will gain insights into:
- How TEM plays a fundamental role within a cell line characterization package, alongside both traditional and novel methods
- The capabilities of TEM for the detection of a range of adventitious agents
- How to apply the latest regulatory guidance to testing strategy by selecting and integrating various complementary assays with TEM, based on the specific cell type
Xtalks Partner
MilliporeSigma
MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Our BioReliance® biosafety testing and analytical development services deliver risk-mitigating solutions with technical and regulatory expertise. We partner with clients through the product cycle, from early pre-clinical development through licensed production, to help ensure the safety of the world’s therapeutics.
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