Best Technology Application – UPSTREAM
Ranger Service – Stratophase
Ranger™ is an innovation in cell culture upstream process development that, for the first time, permits changes in the metabolic rate of cell cultures to be measured in real-time and on-line. This information then allows for process parameter changes to keep the cells in an optimally active and healthy condition. Use of this innovative new approach in cell culture process development has resulted in multiple benefits: more robust processes developed, shorter timelines and improved productivity. This new approach provides insights into the dynamics of the cell culture process that were not previously available.
Short/Long Term Benefits
The Ranger™ service supports process development scientists to measure changes in the metabolic rate of a cell culture and allows corresponding process parameter changes, such as feeds, to be automatically triggered to maximise cell metabolic rate. This achieves healthier cells, producing higher product titres, minimises process risk and leads to a consistent and repeatable product quality. Ranger™ provides real-time, on-line, automated process parameter control and optimisation, such as for cell culture feeding. This leads to many valuable benefits in bioprocess development and competitive advantage for biopharmaceutical companies. Critically important benefits include: – speedier process development – more robust processes with less inherent risk – higher product titres, realised earlier on in development – healthier cells producing consistent product – an effective increase in limited process development capacity and overall a lower cost of goods .
BioProfile Flex 2 Comprehensive Modular Cell Culture Analyzer – Nova Biomedical
FLEX2 was developed for all areas of cell culture. High throughput design with analysis times as fast as two minutes per sample, coupled with extremely low sample volume requirements as low as 105uL provides the industry’s only solution for high throughput screening studies and enables sampling of small volume culture systems. Three unique sampling modes offer the ultimate flexibility for labs running many types of culture systems. Manual syringe mode provides results for all tests while providing the highest accuracy of gas and pH measurements of any cell culture analyzer. A 24 position external “load and go” carousel provides the most efficient sampling mode for both sequential sampling as well as batch analysis of multiple samples. FLEX2 can also sample directly from 96 well microtiter plates, both deep and shallow well configurations. FLEX2 is the only cell culture analyzer capable of sampling from microbioreactor culture systems AND providing a comprehensive panel of results.
Short/Long Term Benefits
BioProfile FLEX2 is the only cell culture analyzer with a maintenance-free MicroSensor Card design, yet with a modular comprehensive test menu to handle all cell culture applications. FLEX2’s small sample volume requirements coupled with fast analysis times and no need for pre-dilutions allows for acceleration of product development timelines and labor resource savings. FLEX2 assists with seamless technology transfer of processes from cell line development through GMP manufacturing.
Sedimentation in an Automated Microbioreactor (SAM) – Glycotope
The SAM model is ideal for selecting clones that will produce product with the desired product quality characteristics. Product produced in the SAM model has highly comparable glycosylation patterns and other product quality attributes to that from the 1 L-scale. Furthermore, Glycotope have shown consistent glycosylation profiles between the 12 mL and 1000 L scales. Glycotope have demonstrated that the SAM model is ideally suited for optimizing cell cultures using a DoE methodology. In one experiment they performed, they ran 18 perfusion cultures in parallel using the ambr®15 systems and were able to identify optimum operating conditions. To perform the equivalent experiment at the 1L –scale would have been costly, time consuming and labour-intensive.
Short/Long Term Benefits
This fully automated, scale-down perfusion method requires minimal operator intervention and therefore has been shown to be highly reproducible and labor-efficient. The technology reduces the amount of cell culture media required to perform perfusion optimization studies that can be a significant development costs. The SAM model reduces the time taken to bring products to the clinic through its capability to operate perfusion experiments in parallel. The ease with which large datasets can be generated using the ambr®-based technology is allowing more highly optimized process to be developed than would otherwise been possible while still ensuring that product quality attributes will be achieved upon scale-up.