Agenda

10:00 – 10:05

Moderator Introduction

10:05 – 10:35

Screening of Antibody Expressing Clones with an Automated Deep Well System
Benjamin Wang, Scientist, Medimmune

Abstract
Large numbers of clones must be evaluated during cell line development in order to find those with the highest antibody production levels. Miniaturized systems such as multiwell plates allow many clones to be cultured simultaneously in a small footprint, but the appropriate type of plates and conditions must be chosen so that the cell growth and antibody production characteristics in wells match those in larger vessels such as shake flasks. Furthermore, automation is required for optimal and practical use of these systems for cell line development applications. In this talk, we will present our results using a fed-batch deep well culturing platform with an automated liquid handling and measurement system which can be used to identify high titer monoclonal antibody expressing cell lines.

10:35 – 11:05

ForteBio Octet RED384 in Antibody Discovery at Adimab Inc.
Hemanta Baruah, Scientist 1, Adimab Inc.

Abstract
At Adimab, Octet RED384 is a key component in our high throughput affinity screening and ranking of hundreds of purified antibodies selected from our proprietary Yeast presentation platform. The Octet RED384 system is very efficient in performing extensive epitope binning of our antibodies.  Also, Adimab has established a rigorous and robust method for measuring antibodies with very high affinity. With our method, reliable measurement of koff values up to 1.0E-05 s^-1 is possible.

11:05 – 11:15

Lunch

11:15 – 11:45

The Use of Bio-layer Interferometry (BLI) for Quantitation of a Humanized Antibody Therapeutic
Mark Dysinger, Research Scientist, Pfizer

Abstract  
Bio-layer Interferometry (BLI) is an established technology for evaluating the kinetic properties of ligand binding reagents and protein therapeutics. There are also some practical utilities for using this platform to quantify biotherapeutics. Here we present strategy and results for the development and qualification of an Octet assay for the quantitation of a humanized antibody therapeutic with reagents previously used in a validated ELISA. Octet qualification and ELISA validation results are compared, and samples analyzed by the ELISA in support of a toxicokinetic (TK) study are analyzed via Octet. From these results we draw conclusions about the practical quantitative use of BLI in both non-GLP and GLP environments.

11:45 – 12:15

Host Cell Protein Testing Using the ForteBio Octet Platform
Martha Jackson, Staff Scientist I, Wyeth

Abstract
Beta testing for Host Cell Protein (HCP) was performed at two Pfizer sites as a blinded study using the ForteBio Octet HCP application. Each site performed the basic method performance parameters: specificity, assay range, method robustness, accuracy, recovery and sensitivity. Sample analysis was also performed to determine HCP removal, batch consistency and equivalence to current HCP analytical methods.

The Forte Bio Octet HCP application offers an analytical method to monitor HCP from 1 to 100 ng/mL. Recovery was demonstrated at 1 ng HCP/mL. Accuracy was demonstrated at 1 ng HCP/mg of API for a sensitivity of 1PPM. Assay robustness for the Octet HCP application was equivalent to established HCP methods. The specificity of the reagents was adequate to measure HCP in samples and demonstrate HCP removal across purification processes and consistency across batches. The HCP application is easily transferred and results were equivalent across the two sites.

12:15 -12:45 

Speaker Panel Discussion