With a goal of improving quality for therapeutic proteins and monoclonal antibodies, as well as creating mechanisms for approval of follow on protein products (biosimilars), the FDA has encouraged the industry to submit biological new drug applications that include quality by design (QbD) parameters. QbD approaches require multivariate experimentation techniques that generate large numbers of samples and create bottlenecks in sample preparation and analysis.
“The Staccato Protein Workstation is designed to address the sample preparation and analysis bottlenecks caused by increased sample requirements of QbD approaches and is also directly applicable to research groups performing protein expression optimization, clone selection, and other high throughput techniques,” said Kevin Keras, Business Unit Manager, ACES, Caliper Life Sciences. “Caliper has worked with several of our LabChip GX customers, including Dow and Amgen, to develop custom automation solutions to integrate sample preparation and analysis steps. Recognizing the broader need for this workflow automation, Caliper has created the Staccato Protein Workstation as an off-the-shelf solution.”
The Staccato Protein Workstation, developed by Caliper’s Automation, Consulting, Engineering, and Services (ACES) group, incorporates the Sciclone ALH 3000 for automated liquid handling, Twister II for microplate handling, LabChip GXII for microfluidic protein characterization, and various accessories for complete workflow automation. The LabChip GXII is Caliper’s high throughput system for analyzing protein size, concentration, and purity and serves as a replacement for traditional polyacrylamide gel electrophoresis (PAGE). Since its launch in July, 2008, the LabChip GX platform has been widely adopted by high throughput protein analysis laboratories including companies such as Merck, Novartis, GSK Biologics and Eli Lilly; government and academic institutions such as National Cancer Institute, Howard Hughes Medical Institute, Sandia National Laboratories, University of Queensland, and Karlshrue Institute of Technology, and biotechnology companies such as Amgen, XcellereX, and ICx Biosystems.
For additional information on Caliper’s research tools for sample preparation and QC of biologicals, please visit http://www.caliperls.com/products/aces/staccato-protein-workstations.htm.
