I am not particularly spiritual. But as the shadow of the moon began to approach on August 21, 2017, I started to think about the limits of my knowledge of the solar system, galaxies, and beyond, compared to my focus for decades on smaller objects, such as molecules, cells, and tissues. A week later, Hurricane Harvey developed rapidly and lingered over southeast Texas, dumping over 50 inches of rain in some locations, causing widespread flooding, releasing sewage and toxic chemicals into the water, and triggering outbreaks of mold. Hurricane Irma, on its path through the Caribbean and up the western coast of Florida, devastated vegetation, buildings, and power lines, with intense winds that once peaked at 185 mph…
BioProcessing Journal Posts
Because the Lambda MINIFOR bioreactor provides good mixing of cell culture, nutrients, and gases without any damaging hydrodynamic forces by using a bio-mimicking “fish-tail“ disc stirrer, it can be successfully applied for the cultivation of bacteria and yeast, insect, plant, and mammalian cells. However, reports on its application in mouse hybridoma cell culture using protein-free media is non-existent in the scientific literature. Therefore, this study describes preliminary findings of the Lambda MINIFOR bioreactor suitability in mouse hybridoma cell culture and antibody production using the SP2/O-Ag14-CB.Hep-1 mouse hybridoma cell and the PFHM-II protein-free medium as models. Results verified 2.45 × 106 viable cells/mL as the highest cell concentration, 86% as maximum cell viability, 0.0156/h as the exponential growth rate, 44 h as cell population doubling time, a stable phenotype measured by limiting dilution after 2.5 months, no antibiotic and antifoam requirements, 71.4% of IgG SDS-PAGE purity in the cell culture harvested supernatant, 38.68 ± 22.29 µg/mL, 39.23 ± 10.66 pg/cell/day, up to 99.5% of purity (sample measured by SDS-PAGE and SE-HPLC) after an IgG capture step based on protein A-Sepharose, a low pH incubation, and size-exclusion chromatography, no molecule aggregation, specificity for the CKTCTT epitope (located in the HBsAg “a” determinant), an IgG affinity constant equal to 1.11 × 1010 M-1, and < 78 pg mouse DNA/mg of IgG. In conclusion, this study corroborated a cumulative CB.Hep-1 mAb production of 1.77 g/15 days and validated the usefulness of the Lambda MINIFOR bioreactor in mouse hybridoma cell culture in protein-free media for research applications...
Automation in bioprocessing was a keynote topic at the ISBioTech 4th Annual Fall Meeting (December 12–14, 2016) in Virginia Beach, VA. Automation is becoming increasingly critical as biomanufacturers seek to improve their production efficiency and critical risk analysis, and reduce errors. But despite recent improvements and innovations, the actual integration of devices, software, sensors, and production equipment remains a challenge. In BioPlan Associates’ recent analysis of capacity and production, we found that nearly 20% of the biopharma industry sees increasing productivity and efficiency as the #1 critical issue the industry needs to focus on today. And over two-thirds expect better control of their processes. An obvious way to achieve these goals is through automation…
The same sensor instrumentation can now be used in process development laboratories, clinical trials, pilot plants, and large-scale manufacturing — thus simplifying product development, scale-up, and regulatory record-keeping…
In a world already awash with technology, life sciences companies are racing to add more automation and data sources, while ironically often spending less time focused on process improvements. In some cases, these two opposing actions can still produce positive results by: (a) reducing manual labor to minimize data translation errors; (b) adding sensors to gather a new kind of data about a protein or a process; or (c) implementing high-throughput techniques for biopharmaceutical development. But what about those situations where collecting new data is not so positive? Does it really make sense to run experiments without the full benefits of accessing accumulated data or gathering new data? Or to proceed without the insights gained from a colleague down the hall or at another site working on a related project? The difficulty in realizing these potential data analytics benefits often arises because more sensors tend to produce large, complex datasets with multivariate interactions. Further, the inherently complex nature of these datasets makes extraction of meaningful and relevant information a challenging task. This is where a streamlined data analytics methodology can help by providing the foundation to realize the benefits from all of this new data. This article illustrates how a comprehensive data analytics methodology can be used to develop insight into life sciences lab and production data, leading to improved operations. The focus is on sharing lessons learned from recent pharmaceutical case studies to illustrate how to drive innovation through use of a data analytics methodology. These case studies provide detailed, data-driven examples illustrating how to utilize a data analytics methodology to uncover important issues related to pharmaceutical development…