Process Development
Process Development
In a MAb platform approach, chromatography media and other materials are fixed so the effort for basic development and optimization of each method is significantly lower than using a random approach to process design.
A typical MAb production workflow includes culturing mammalian cell lines (e.g., CHO cells or murine myeloma NS0 cells) and harvesting by centrifugation. Usually, downstream purification begins with Protein A-based capture, followed by virus clearance and filtration, and just one or two additional chromatography steps. The last step is typically cross flow filtration (CFF/TFF) to formulate the purified bulk material.
High Throughput Process Development (HTPD) speeds up your progress to production by allowing you to rapidly screen a large experimental space and select the most promising avenues to explore.
PreDictor 96-well Filter Plates are prefilled with BioProcess chromatography media and allow you to screen several different chromatography media in parallel, shortening development time. Because the generated data show a good correlation with that obtained using chromatography columns, PreDictor plates offer an efficient means to rapidly screen process conditions, while using significantly less sample.
PreDictor RoboColumn miniaturized columns also support HTPD by allowing parallel screening of chromatographic conditions using a robotic workstation. The columns are prepacked with BioProcess media and consume limited amounts of sample.
After exploring a large experimental space, a smaller subspace can be investigated prior to final process optimization and scale-up. HiScreen columns are designed for this task.
HiScreen columns are prepacked with a range of BioProcess chromatography media such as MabSelect and Capto. The column volume (4.7 ml) is small enough to save considerably on sample and buffer consumption, while the height (10 cm) forms a good basis for optimizing conditions such as selectivity, capacity, binding and elution. HiScreen columns give reliable results that serve as a basis for linear process scale-up.
