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Achieving Integrated Biologics Development: Challenges and How to Tackle Them

Date: March 12th, 2020
9:00 AM – 4:00 PM

Location: Royal Society of Chemistry
Burlington House (Science Room)
Piccadilly
London, W1J 0BA
U.K

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.

AGENDA

TIME

TOPIC

SPEAKER

9:00 am – 09:30 am
Registration
09:30 am – 09:45 am
Welcome from the Hosts

Christelle Dagoneau, Ph.D.
Senior Account Director,
Catalent Biologics

Alicia Gailliez
Business Development Manager,
One Nucleus

9:45 am – 10:15 am
Improved Methods for Cell Line Development of Difficult to Express Proteins

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

Steven Hager, Ph.D.
Senior Director,
Catalent Biologics

10:15 am – 10:45 am
High Throughput, Automated Bioreactors for Early Process Development

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

Barney Zoro, Ph.D.
Senior Product Manager,
Sartorius Stedim Biotech

10:45 am – 11:15 am
Coffee break & Networking
11:15 am – 11:45 am
Formulation Development with a Focus on Stability and Aggregation

  • 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.
Marketing Manager,
Unchained Labs

11:45 am – 12:15 pm
Speeding Up Drug Product Technical Transfers

  • Assessing risks and developing mitigation plans
  • Standardizing processes and equipment

Sylvain Flandroy
New Product Introduction Program Manager,
Catalent Biologics

12:15 pm – 1:30 pm
Lunch Networking
1:30 pm – 2:00 pm
Using Data Analytics to Drive Operational Efficiencies in Process Development and Manufacturing

  • 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

2:00 pm – 2:30 pm
Advances in Injection Delivery Systems

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

Ian Thompson
Vice President, Business Development,
Ypsomed

2:30 pm – 3:00 pm
Optimizing Clinical Study Management

  • Efficient coordination of clinical supplies
  • Clinical manufacturing, packaging, storage and distribution
  • Integrated approach from development to clinical and benefits to using one vendor

Susan Fuller
Regional Manager, Clinical Supply Manager,
Catalent

Gavin Yates
Director, Customer Service Excellence,
Catalent

3:00 pm – 4:00 pm
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