FORMULATION, FILL & FINISH
SPEAKERS 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