Optimize Cell Line Development for First-in-Human Success:
Building Better Clones
About this webinar
An efficient transition from drug discovery to first-in-human studies requires highly productive clones with the right product quality, scalable processes and rapid process development toward robust GMP manufacturing. Establishing effective cell line development strategies early can help address challenges related to productivity, expression stability and product quality throughout biologics development.
This webinar explores how advances in cell line development, including targeted gene integration, stable pool generation and automated clone screening, can support the selection of producer clones for downstream development and manufacturing.
Gene integration strategies that use transposase-mediated, epigenetically targeted integration direct genes to the most transcriptionally active genomic sites. This can yield bulk pools with high, stable titers and consistent product quality, which can be used early to produce material for early development activities and toxicology studies. Establishing productivity and expression stability early can also allow clone screening efforts to place greater emphasis on product quality and process performance.
Assessing product quality across large numbers of clones remains a critical challenge, and addressing it early opens the door to better clone selection. Automated screening enables earlier evaluation of large clone panels for productivity, upstream process compatibility and critical quality attributes. Combined with advanced product characterization, this can deliver high-quality producer clones in a shorter timeframe, supporting scalable manufacturing and rapid progression towards first-in-human studies.
Register for this webinar to learn how advanced cell line development and smart clone selection can help pave the path to scalable manufacturing and successful first-in-human studies.
Who should attend
- Cell Line Development Scientists and leaders
- CMC and Bioprocess Development professionals
- Upstream Process Development Scientists and Managers
- Technical Operations and Manufacturing Development leaders
- Biologics program and project leaders preparing candidates for first-in-human development
- Biotech and pharma teams evaluating cell line development strategies and CDMO approaches
What you will learn
- Why early cell line development decisions are important for transitioning biologics candidate into first-in-human studies
- How targeted gene integration strategies can support productivity, expression stability and product quality during cell line development
- How automated clone screening can improve the evaluation of productivity, critical quality attributes and upstream process compatibility to support scalable manufacturing
Featured Speakers
Thomas Rose, PhD
Thomas Rose, PhD, is Director of Expression Systems at ProBioGen. He received his MSc in Biotechnology from the University of Applied Science in Berlin and his PhD in Biochemistry from the Free University of Berlin before joining ProBioGen in 2001. His work focuses on cell line development and expression technologies for protein drugs. He was instrumental in establishing the Freedom™ CHO-S™ Kit, as well as ProBioGen’s CHO.RiGHT® platform, Pathway Modulator and DirectedLuck® technologies. He also has extensive experience in cell line development for a variety of complex proteins.
Partner for this event
ProBioGen
ProBioGen is a fully integrated contract development and manufacturing organization (CDMO) specializing in biopharmaceuticals, viral vectors, and vaccines. We offer high-performance cell line development, robust process optimization, reliable GMP manufacturing, and advanced analytical services. Leveraging proprietary technologies, we deliver high yields while ensuring exceptional potency and quality, while our expertise spans therapeutic proteins, viral vaccines, and cell and gene therapies. As a trusted partner, ProBioGen provides tailored, scalable solutions that address complex development and manufacturing challenges—from early-stage development to GMP production.
For more information, visit our website or follow us on LinkedIn.