An intercompany perspective on compatibility and in-use stability studies to enable administration of biopharmaceutical drug products
Broadcast date
Wed, May 18, 2022
Presented by
- Douglas E Kamen - RegeneronQingyan Hu - RegeneronGeorge Crotts - GlaxoSmithKline R&DBrittney Mills - AbbVieFrancisca Gbormittah - GlaxoSmithKline SED, formerly at AlkermesChakravarthy Nachu Narasimha - MerckElaine S.E. Stokes - BioPhorum
Quick Description
BioPhorum’s Development Group Formulation Workstream highlight results from five benchmarking surveys for biologic drugs. The results include various approaches that can be used to guide the strategy and design of an in-use stability and compatibility program based on clinical and biomolecule needs.
Details
With the increased complexity of biopharmaceutical modalities, study sponsors and stakeholders must develop appropriate in-use stability and compatibility practices. This webinar provides insights for biopharmaceutical companies into the practicalities of these studies and how they are being used to support the administration of biologics from early clinical programs to marketed products.BioPhorum’s Development Group Formulation Workstream highlight results from five benchmarking surveys for biologic drugs. The results include various approaches that can be used to guide the strategy and design of an in-use stability and compatibility program based on clinical and biomolecule needs.The paper was published in the Journal of Pharmaceutical Sciences in April 2022.
Speakers
Douglas E Kamen
Associate Director
Regeneron
Qingyan Hu
Associate Director
Regeneron
George Crotts
Director
GlaxoSmithKline R&D
Brittney Mills
Principal Research Scientist
AbbVie
Francisca Gbormittah
Sr Manager
GlaxoSmithKline SED, formerly at Alkermes
Chakravarthy Nachu Narasimha
Senior Principal Scientist
Merck
Elaine S.E. Stokes
Lead Facilitator
BioPhorum