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 - Regeneron
    Qingyan Hu - Regeneron
    George Crotts - GlaxoSmithKline R&D
    Brittney Mills - AbbVie
    Francisca Gbormittah - GlaxoSmithKline SED, formerly at Alkermes
    Chakravarthy Nachu Narasimha - Merck
    Elaine 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