For over 40 years, we have been innovating to become the leader in process chromatography.
Novasep has pioneered simulated moving bed (SMB) chromatography and our continuous chromatography technologies have demonstrated superior performance in the purification of APIs and many other ingredients of the life science industries. We have successfully managed the validation and regulatory approval of our multicolumn processes for commercial API production by regulatory authorities such as the US FDA.
With the introduction of the Prochrom® BioSC Sequential Multicolumn Chromatography System (SMCC), we are addressing three key challenges which are critical for the effective downstream processing of biologics, particularly for the capture and intermediate purification (such as ion exchange) steps:
Click here to see the movie explaining how the Prochrom® BioSC operates.
Prochrom® BioSC® does not compromise between quality and productivity through smarter use of resin, lower consumption of buffer and reduced investment.
Novasep has over 15 years of experience in manufacturing multicolumn chromatography systems for pharmaceutical and biopharmaceutical productions. With our proprietary modeling tools, Novasep engineers can rapidly optimize your multicolumn process. Once the optimal SMCC process has been defined, the recipe is implemented on an automated lab-scale BioSC® and the selected parameters are tested. These simulations have proven to be highly accurate and predictable and only 1 or 2 trials are required to obtain targeted purity and recovery yield. The automated process control supported by Process Analytical Technologies (PAT) allows an efficient process, with very low variability and excellent reproducibility over time.
Using BioSC® allows you to reduce by 2-4 fold the amount of resin required. In comparison with conventional (batch) chromatography processes, BioSC® optimizes the resin utilization rate and allow a higher velocity. Due to the increased productivity (g protein/L stationary phase/day) the quantity of stationary phase can be reduced proportionally up to a factor of four. The full automation and the (quasi-)continuous process allow for unattended production runs, thus greatly lowering manpower requirements.
Our proprietary in-line dilution technology enables you to directly prepare buffer from water and concentrated buffer solutions, hence avoiding large storage capacities, reducing associated floor space and saving on capital investment. Our in-line mixing technology is either supplied as stand-alone units or integrated in our Prochrom® BioSC sequential multicolumn chromatography systems. Our technology is based on the use of mass flow meters or conductivity-meters coupled with a specific control system to reach the highest reproducibility. These systems allow much smaller buffer tanks within your biomanufacturing plant.
Since the BioSC® system includes several small columns and in-line buffer dilution functions, disposable elements can be integrated in the process to reduce the cleaning and validation burden of your biopharmaceutical production.
Full automation and flexible asynchronous scheduling of multiple columns (three to six) enable processes to run at linear velocities over 1,000 cm/h. while effectively utilizing almost 100% of the capacity of the resin. Byapproaching the maximum loading capacity while increasing process velocity, the end result is significantly improved productivity by 1.5 to 4 fold compared with traditional chromatography steps.
Prochrom® BioSC systems are ideal for the following downstream processing needs:
Capture, intermediate purification and polishing of:
using, for example, affinity, ion exchange or hydrophobic chromatography media.
In batch processing, the industry is faced with managing the "Productivity Paradigm": run at slower flow rates and produce more grams of protein per mL resin or run a faster process but at lower dynamic capacity.
For almost any chromatographic process, SMCC will break the "Productivity Paradigm" demonstrating improvements in speed, productivity and stationary phase usage of up to 3-fold as well as a reduction in buffer and wash fluid solutions of up to 4-fold, while maintaining both purity and yield performance. The uniqueness of the Prochrom® BioSC SMCC technology lies in its management of "fluid-in" and "fluid-out" and the ability to asynchronously and flexibly schedule each of the multiple columns.
Prochrom® BioSC cuts your downstream processing cost in half by:
Our engineers design units, ideally suited to your facilities and specific process needs.
|Number of Columns||2 to 6|
|Productivity Range (kg/day)||< 0.01||0.1||3||Customized|
|Typical Column Diameter (mm)||5-8-10-11||10 to 26||50 to 150|
|Max Flow Rate (L/h)||1||5||150|
|Standard Max Operating Pressure (bar)||6||6||6|
|70 x 100 x 60||200 x 100 x 100||200 x 200 x 100|
For more information, please take a few seconds to download the Prochrom® BioSC brochure.
ChromSoft Prochrom® BioSC control software provides automated and safe operation of the solvent module under cGMP conditions:
ChromSoft Prochrom® BioSC software provides user-friendly, secure, traceable productions.
Main functions include:
Range of biochromatography solutions:
Range of TFF solutions:
Download our brochures for biologics manufacturing.
For any questions on Novasep's purification/separation services and equipment for biologics, please contact us.