Prochrom® BioSC: Sequential Multicolumn Biochromatography for Biologics Production

We bring innovation to improve downstream processing

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:

• Improving productivity
• Cutting purification costs
• Supporting PAT initiatives

Click here to see the movie explaining how the Prochrom® BioSC operates.

Solution for Improved Biomanufacturing Processes – your Benefits

Prochrom® BioSC® does not compromise between quality and productivity through smarter use of resin, lower consumption of buffer and reduced investment.

Process Robustness

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.

Reduced Consumables and Labor Costs

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.

Downsized DSP Systems and Utilities

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.

More Disposable Alternatives

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.

Improvement of Yield and Productivity

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.

Typical Applications of Sequential Multicolumn Biochromatography

Prochrom® BioSC systems are ideal for the following downstream processing needs:

Capture, intermediate purification and polishing of:

• Proteins: e.g.:
  • Monoclonal antibodies (mAbs)
  • Blood / plasma factors
  • Recombinant proteins
• Vaccines
• Viruses
• Blood fractions
  

using, for example, affinity, ion exchange or hydrophobic chromatography media.

Theoretical Principles of  Sequential Multicolumn Chromatography

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.

Key Assets of Prochrom® BioSC

Prochrom® BioSC cuts your downstream processing cost in half by:

• Significantly improving usage of expensive stationary phase
• Substantially reducing CIP and buffer usage
• Integrating in-line dilution within the chromatographic system
• Downsizing of downstream processing systems and utilities
• Significantly faster processing
• Reducing labor costs through automated process control and in-process analyses
• Supporting PAT initiatives
• Enabling continuous downstream processing
• Improving yield

BioSC® Product Line                                                              

Our engineers design units, ideally suited to your facilities and specific process needs.

	BioSC®
Standard Features	Lab	S	M	L
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
Dimensions WxHxD (cm)	70 x 100 x  60	200 x 100 x 100	200 x 200 x 100
Weight (kg)	150	200	700

For more information, please take a few seconds to download the Prochrom® BioSC brochure.

Software - Chromsoft Prochrom® BioSC

ChromSoft Prochrom® BioSC control software provides automated and safe operation of the solvent module under cGMP conditions:

• Industrial PLC equipped with PC interface
• Validated software based on GAMP 5 and compliant with 21 CFR part 11
• Same software from lab to industrial scale for seamless scale-up

ChromSoft Prochrom® BioSC software provides user-friendly, secure, traceable productions.
Main functions include:

• Multi-level access control
• Recipe editor
• Linear and step gradient capabilities
• Real-time monitoring of all process parameters
• Conflict safeguard logic
• Historical data logging

Download our brochures for biologics manufacturing.

For any questions on Novasep's purification/separation services and equipment for biologics, please contact us.