Achieving Integrated Biologics Development: Challenges and How to Tackle Them
Date: March 12th, 2020
9:00 AM – 4:00 PM
Location: Burlington House
London, W1J 0BA
To register for this free event, please email Alicia@onenucleus.com
A comprehensive end-to-end solution from biologics development, clinical to commercial-scale manufacturing and finished product supply has the potential to provide higher quality and improved yield of biopharmaceuticals with reduced cost and time. Compared to small molecules, the selection, characterization, drug substance manufacturing and drug product development are all more complex. Decisions during early development can have an impact on the likelihood of clinical and commercial success. Therefore, it is important to understand the integrated nature of biologics development. This event will focus on key considerations for transitioning a molecule from clinical to commercial beginning with cell line development and biomanufacturing to formulation and filling, through patient delivery methods and management of clinical supply studies. The incorporation of data analytics and multivariate modeling tools to support the analysis of scale-down model of the cGMP manufacturing process will also be discussed.
Christelle Dagoneau, Ph.D.
Senior Account Director,
Business Development Manager,
- GPEx Boost: Cell line engineering approaches
- Improve titers and cell-specific productivity
- Why GPEx Boost is faster to clinic
Steven Hager, Ph.D.
- Process intensification (perfusion)
- Process characterization
- Scalability to larger bioreactors
Barney Zoro, Ph.D.
Senior Product Manager,
Sartorius Stedim Biotech
- Chemical and physical stability of proteins
- Early assessment of aggregation issues
- Pre-formulation screening by stability
- Other applications of stability assessment tools
Kevin Lance, Ph.D.
- Assessing risks and developing mitigation plans
- Standardizing processes and equipment
New Product Introduction Program Manager,
- Application of DoE and multivariate analytics for alignment of critical process parameters, comparability across different scales and prediction of product quality heterogeneity
- Mechanistic understanding of systems biology modelling via data analytics
Mark Demesmaeker, Ph.D.
Head of Data Analytics,
Sartorius Stedim Data Analytics
- Injection delivery market overview
- Platform technology strategies
- Large volume and connectivity therapy trends
- Latest usability insights
Vice President, Business Development,
- Efficient coordination of clinical supplies
- Clinical manufacturing, packaging, storage and distribution
- Integrated approach from development to clinical and benefits to using one vendor
Regional Manager, Clinical Supply Manager,
Director, Customer Service Excellence,
- Following the meeting, all presenters and Catalent experts will be available for private, no-obligation discussions on specific programs and challenges