Attendance at this event is complimentary. This event is mainly targeting companies involved in manufacturing therapeutic drug products. Please note, all registrations are subject to the approval of the sponsor and Catalent reserve the right to refuse any registration. You will be informed if your registration has been cancelled within 2 working days of registering online for the event.

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.

Programme

09:00  Registration

09:30  Welcome from Hosts

Alicia Gailliez, One Nucleus

Dr Christelle Dagoneau, Senior Account Director, Catalent Biologics

09:45  Improved Methods for Cell Line Development of Difficult to Express Proteins

Dr Steven Hager, Senior Director, Catalent Biologics

• GPEx Boost: Cell line engineering approaches
• Improve titers and cell-specific productivity
• Why GPEx Boost is faster to clinic

10:15  High Throughput, Automated Bioreactors for Early Process Development

Dr Barney Zoro, Senior Product Manager, Sartorius Stedim Biotech

• Process intensification (perfusion)
• Process characterization
• Scalability to larger bioreactors

10:45  Coffee Break

11:15  Formulation Development with a Focus on Stability and Aggregation

Dr Kevin Lance, Marketing Manager, Unchained Labs

• Chemical and physical stability of proteins
• Early assessment of aggregation issues
• Pre-formulation screening by stability
• Other applications of stability assessment tools

11:45  Speeding Up Drug Product Technical Transfers

Sylvain Flandroy, New Product Introduction Program Manager, Catalent Biologic

• Assessing risks and developing mitigation plans

• Standardizing processes and equipment

12:15  Networking Lunch

13:30  Using Data Analytics to Drive Operational Efficiencies in Process Development and Manufacturing

Dr Mark Demesmaeker, Head of Data Analytics, Sartorius Stedim Data Analytics

• 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

14:00  Advances in Injection Delivery Systems

Ian Thompson, Vice President, Business Development, Ypsomed

• Injection delivery market overview
• Platform technology strategies
• Large volume and connectivity therapy trends
• Latest usability insights

14:30  Optimizing Clinical Study Management

Susan Fuller, Regional Manager, Clinical Supply Manager, Catalent

Gavin Yates, Director, Customer Service Excellence, Catalent

15:00  1:1 Private Consultancy Appointments

Following the meeting, all presenters and Catalent experts will be available for private, no-obligation discussions on specific programs and challenges

16:00  Close
 

*This button will not work if you are not logged in*