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New Horizons in Biologics & Bioprocessing

Schedule a Meeting with Catalent at New Horizons in Biologics & Bioprocessing

Date: December 15th 2022
Location: Stockholm Waterfront Congress Centre, Stockholm, Sweden
Booth: Catalent

In collaboration with

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FEATURED SPEAKER

 

Paresh Vadgama's headshot

Paresh Vadgama
Fellow Scientist, Product Development, Catalent Biologics

 

 

Session Title: Pathways to Speed up Product CMC Development for the First-in-Human Clinical Trials
Abstract:

Biological drug products are the leading class of therapeutics being developed to meet unmet medical needs. These are complex modalities and require sophisticated manufacturing technologies, that in turn brings a lot of technical challenges. Moreover, there will be a constant pressure to balance the costs, development speed and external competition especially at the early stage of CMC development. At Catalent, we share a common goal to put the patient first and bring to them better and healthier lives. In this presentation, we will display implementable drug product formulation and process development strategies that can be opted for a balanced approach towards speeding CMC development for first-in-human clinical trials.