See how fellow Biacore users are improving protein characterization with
Watch these exclusive videos from the Biacore Analytical, Comparability and QC Symposium, Vienna, Nov 2017, industry luminaries share insights, tips and techniques that illuminate how SPR with Biacore system is helping advance biotherapeutics research and production.
surface plasmon resonance (SPR).
Start off with a deep dive into a range of assays using Biacore systems to evaluate potency. Followed by Fredrik Sundberg’s insights into global industry and regulatory trends.
Mike Wilcox on compliant Fc receptor potency validationAn important step in the development of mAb biosimilars is to compare binding to Fc receptors of the new therapeutic to the reference medicine. To do this, in vitro functional testing methods are paramount, as outlined by guidelines presented in the 2005 report by the European Medical Agency.
Watch this video where Eurofins Biopharma shares how to perform an SPR assay to validate Fc receptor potency according to ICH Q2 R1 and FDA guidelines.
Qualification of an SPR kinetics (CD64) and steady state affinity (FcRn) assay
based on the ICHQ2 (R1) guidelines
Presenter: Mike Wilcox, Eurofins
Playing time: 18 minutes
Stuart Knowling explores SPR in relative potency assaysAll biological products must meet prescribed safety, purity and potency requirements for BLA approval. Potency is considered a critical quality attribute (CQA) for any biological product, and the implementation of relevant assays is often at the center of many challenges and discussions among developers and regulators throughout product development.
Watch this video to get a taste of how SPR binding and affinity are being used in relative potency assays, and how that correlates with antibody-dependent cell-mediated cytotoxicity (ADCC) in work being conducted at Sartorius Stedim BioOutsource.
Using SPR-based assays for comparability and potency assessment
Presenter: Stuart Knowling, BioOutsource
Playing time: 30 minutes
Veronica Fridh sheds light on SPR surrogate potency assaysThe utilization of SPR in process optimization and quality control is increasing, due to the combination of robustness, high sensitivity, precision, and accuracy that Biacore SPR technology provides. This, coupled with high throughput capabilities and decreased sample preparation requirements, is why SPR is an attractive method relative to traditional analytical techniques that measure protein quantity and quality.
Watch this video on how SPR surrogate potency assays facilitate comparability biosimilar studies.
High-resolution SPR surrogate potency assay to facilitate comparability
and biosimilar studies
Presenter: Veronica Fridh, GE Healthcare Life Sciences, R&D
Playing time: 21 minutes
Fredrik Sundberg on global bioprocessing industry and regulatory trendsA thorough understanding of your drug development process and how it affects your product’s critical quality attributes is essential for decision-making, development and scale up. Are you up-to-date with new analytical platforms that can give you the edge?
Watch this video to get an overview of global industry and regulatory trends and how Biacore assays can be employed to ensure drug safety and efficacy.
Global industry trends and health authority acceptance of SPR
Presenter: Fredrik Sundberg, GE Healthcare Life Sciences
Playing time: 40 minutes
Learn more! Check out the Bioanalytics in drug development
web page for a wealth of additional resources.
Christina Burtsoff Asp