BioProcess International West 2019
March 11-14, 2019, Santa Clara, CA
We are excited for this year’s BioProcess International Conference in Santa Clara, California. Visit booth 419 and discover how Aragen Bioscience can move your pre-clinial research projects forward. Don’t miss our poster!
An Integrated Stepwise Approach to Developability Assessment of Therapeutic Antibody Candidates from Discovery to Development
Felix Vega, Tim Myles, Amisha Kizhakkedathu*
- Royalty-free technology for protein expression
- Demonstrated to increase titers up to 3x
- Combine with Aragen’s stable CHO-DG44 to create robust manufacturing cell lines
The developability of a candidate drug protein is a strong indicator whether it can successfully be developed into a viable drug, since developability challenges can adversely impact production consistency, shipping and handling excursions, and long-term storage. Therefore, it is increasingly important to perform developability assessments to mitigate this risk and the risk of costly late-stage failures.
In this poster, we propose an integrated approach to developability assessment starting from early discovery through late process development. We present few example data to visualize the concept. First step is to integrate ForteBio’s high throughput Octet® and Unchained Lab’s high throughput Uncle during early stage discovery for developability screening using potency, self-interaction (technique CSI-BLI) or cross-interaction (CI-BLI), thermal stability, and aggregation propensity data. Hundreds of candidates can be screened in just a few hours with minimal sample consumption using this approach. Promising candidates can then be evaluated using relatively lower throughput methods like Biacore, standup monolayer adsorption chromatography (SMAC), size exclusion chromatography (SEC), and capillary electrophoresis (CE) for developability assessment using molecule properties including binding kinetics, colloidal stability, aggregation, fragmentation, charge variants. This approach can lead to the early identification of developable candidates, significantly reducing the time and cost of downstream manufacturing.
Resolving Precipitation Issues of an Antibody-Fusion During Protein A Purification Through Flocculation
Rene Pagila*, Michelle Stroud and Tim Myles
Two distinct antibody-fusion proteins that share a common fusion partner expressed well in a transient CHO system, however, both have the propensity to precipitate upon elution during Protein A purification. Employing flocculation on the Protein A starting material resolved the precipitation issue.