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Quality Control of Biotherapeutics Using Octet® Systems

Quality Control of Biotherapeutics Using Octet® Systems
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Quality Control of Biotherapeutics Using Octet® Systems - 1

Application Guide October 1, 2022 Keywords or phrases: Quality control, GxP biotherapeutics, process development, product attributes, design of experiments Quality Control of Biotherapeutics Using Octet® Systems David Apiyo, Sartorius, Fremont, CA Correspondence Email: octet@sartorius.com Abstract The Octet® family of Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing, and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. These systems offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. Octet® assays are label-free, fully automated, require much less user intervention, and provide a simplified workflow. All Octet® systems are GxP ready and are widely adopted in regulated environments. The microplate-based sample format is ideal for Design of Experiments (DoE), and, ready-to-use or customizable biosensors create a robust and flexible platform that can also accommodate direct analysis of crude samples. Find out more: www.sartorius.c

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Quality Control of Biotherapeutics Using Octet® Systems - 2

Bio-Layer Interferometry (BLI) has been rapidly adopted as an important analytical tool in laboratories that work with biological molecules, either as drug products, vaccines, or diagnostic reagents. Widely used and accepted in research and assay development, BLI assays are now also utilized for quality control (QC) in biologics development workflows for ligand binding and product quantitation during lot release and in-process testing. Octet® systems combine real-time binding analysis with a simple Dip and Read approach for rapid assay and method development. For example, the 8-channel...

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Quality Control of Biotherapeutics Using Octet® Systems - 3

Global ﬁtting for kinetics Figure 1: (A) Kinetic analysis of the interaction between a ligand biotin-Fcγ Receptor (~55 kDa) and analyte hIgG (150 kDa) with SAX2 Biosensor, overlaying three lots of SAX2 and raw data aligned at the ligand loading step. (B) Data was processed and curve fitted using a 1:1 binding model. See the Sartorius datasheet, High Precision Streptavidin 2.0 (SAX2) Biosensors for ligand loading specifications. Figure 2 and Tables 1 and 2 show exemplary kinetics characterization data for PSA antigen binding to its antibody as derived from the three different Octet® models....

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Quality Control of Biotherapeutics Using Octet® Systems - 4

Table 1: Comparison of biotinylated anti-PSA ligand response on different Octet® models. Data was obtained from two lots of SAX2 Biosensors in duplicate (see Figure 2A). Loading response is reported at 150 seconds. Octet® model 1. Biolayer Interferometry as an Alternative to HPLC for Measuring Product Concentration in Fermentation Broth, Rathore AS et al., LCGC, 35(12) 870–877. Table 2: Octet® kinetics comparability study data shows kinetics parameters for biotinylated anti-PSA antibody immobilized to two different lots of SAX2 Biosensors binding to PSA antigen. Characterization was...

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