Octet® systems enable analytical assessment of biologics in various stages of the development workflow beginning with discovery and early selection to validation, manufacturing and quality control. The instrument’s configuration and sample plate format coupled with real-time analysis allows for rapid assay method development. In the last couple of years, Octet® systems have been used by multiple organizations to generate supporting data submitted to various regulatory bodies for the approval of different biologics drug candidates. In addition, Bio-Layer Interferometry (BLI) technology,…

Single-use process technologies have been increasingly incorporated into the manufacturing of biopharmaceutical products over the past two decades. While the reasons for implementing SU systems for biomanufacturing are compelling, there are still some challenges and concerns related to their use. Process automation is often considered one of the weak points of single-use technology. Automation islands are frequent phenomena with SU systems, and integrating the equipment with larger automation systems is challenging. A number of suppliers – like Cytiva, Merck-Millipore, Sartorius,…

Changes in production scale required due to increasing product needs throughout clinical trials introduces risk to the product development timeline. Both the process and the product can be dramatically impacted from scaling-up to larger production volumes due to changes in the bioreactor microenvironment. By “scaling-out,” instead of “scaling-up” these risks can be mitigated. The “scale-out” biomanufacturing paradigm, which involves simply adding one or more of the same-sized bioreactor to the manufacturing run to obtain the production volume required, can also…

Continuous manufacturing (CM) is increasingly used as an alternative to traditional batch manufacturing of solid pharmaceutical dosage forms. Wet granulation is one of the manufacturing technologies that was successfully migrated from batch to continuous processing. Thereby, the residence time of material under (stress) conditions is significantly reduced which in many cases is a main advantage of CM. However, in other cases with slow transformation processes this raises new challenges. In particular, the question arises as to which process parameters and…

The analytical group at Boehringer Ingelheim, Fremont, USA needed a robust assay to measure the biological activity of an antibody fragment (Fab) molecule for in-process testing as well as stability and lot release testing in their Quality Control (QC) department. The developed Fab activity assay is accurate and robust, with intermediate and intramediate precision less than 10%. Drug activity measurement using the Octet® system has become a critical parameter for their product evaluation and has resulted in increased Fab drug…