BEBPA - BioAssay Conference 2017
St julian's , Malta
Quality Assistance attended the 10th annual EU BEBPA BioAssay Conference !
Potency assays monitor a key quality attribute. It is the assay which ensures that a soon to be released lot of product has the normal, expected biological activity that was tested and found to be efficacious in the clinic.
Clearly this key QC method receives a lot of regulatory scrutiny. Be prepared for this scrutiny by knowing the current trends and expectations. A fun, efficient way to do this is to attend the 10th annual BEBPA Bioassay Conference.
Their sessions included the following topics:
- Assay Development with talks about utilizing DoE in early development, addressing the edge effect in cell based assays and developing potency assays when access to critical rare reagents are limited.
- Antibody Bioassays: with talks about: biosimilarity assessment of Adalimumab and Bevacizumab, develop of reporter based bioassays for immunostimulatory antibodies with varying Fc Gamma receptor dependence, and functional characterization for T-Cell Bispecific antibodies
- More Product Specific Assays: with talks about: Mechanism of Action (MoA) assays to determine the Fc effector functions, candidate assays for immune-oncology, assays for bi-specific protein therapeutics, methods for hematopoietic stem cell therapies and more.
- Life Cycle Management: with talks about: Use of QC control samples for monitoring assays, automation of potency ELISAs, comparing two methods with least squares regression.
Ms Cécile Montagne, Key account manager, Dr Arnaud Delobel, R&D Director and Mr Pierre-Damien Misson and Anne-Sophie Rinaldi, Analytical Team Managers were delighted to welcome you at our booth !
Venue:
Radisson Blu Resort, St Julian's, MaltaMore info:
BEBPA BioAssay Conference website