Speaker presentations include:

Formulation – High concentration biologics and advanced formats 
Chaired by: Shahid Uddin , Head of Formulation, MedImmune

Formulation and analytical challenges in developing biosimilars 
• Importance of orthogonal analytical methods 
• Evaluation of different drug substance (DS) manufacturing methods 
• Screening of drug product (DP) formulations identical or similar to originator 
• Study and comparison of formulation ingredients 
• Comparison of different batches of originator and biosimilar DP 
• Studies of  formulation interactions with human plasma and blood

Tudor Arvinte , CEO, Therapeomic Inc. Basel , Professor, University of Geneva

Aggregation analysis at high and low protein concentrations 
• Aggregation of proteins may occur by a number of different mechanisms, which can lead to a range of aggregate types 
• Using a range of analytical techniques, the formation of protein aggregates by various mechanism has been assessed at low and where possible, at moderate to high protein concentrations 
• The effect of sugars on protein stability will also be discussed

Jennifer McManus , Senior Lecturer in Chemistry, Maynooth University

Formulation – Stability and longevity Adsorption to filter membranes: relevance for administration and manufacturing 
• Filtratration is an important processing step, which a formulated biologic can experience at different stages throughout its lifetime (manufacturing of fully-formulated DS and fill and finish for DP, administration in a clinical setting) 
• Adsorption to filter membranes is one of the common incompatibilities during DP administration in a clinical setting. Finding correlations can help in simplifying compatibility studies. 
• Adsorption to filter membranes during sterile filtration is one of the critical process attributes. Down scale models will be discussed.

Ahmed Besheer , Group Head NBE Formulation Development – Biologics Drug Product Development, Novartis 

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