Sequential Multi-Column Chromatography: BioSC™

Novasep offers Sequential Multi-Column Chromatography for biopharmaceutical production, via its BioSC™ system.

Typical Applications

Capture and purification of:

• Proteins, e.g.:
  • Monoclonal antibodies (mAbs)
  • Blood / plasma factors
  • Recombinant proteins
• Peptides
• Polysaccharides
• Oligonucleotides
• Viruses

Using, for example, affinity, ion exchange, hydrophobic interaction chromatography media.

Theoretical Principle

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 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.

More about operating process of BioSC™ by Novasep

Key Assets of BioSC™

BioSC™ cuts your downstream processing cost in half by:

• Significantly more efficient usage of expensive stationary phase
• Significant reduction in CIP and buffer usage
• Downsizing of downstream processing systems and utilities
• Significantly faster processing
• Reduced labor costs through automated process control and analytical analysis
• Supporting PAT initiatives
• Enabling continuous downstream processing
• Improving yield and purity for Biopharmaceuticals

BioSC™ Product Line

Construction materials:

• 316 L stainless steel, acrylic, glass: borosilicate type I, hastelloy, Teflon® seal (compatible with all organic solvents) or EPDM or PEEK or PTFE,
• ASME-BPE: code of construction,
• full material certification package,
• safety & ergonomic tools,
• sanitary fittings, internal finish better than 0.6 µm, electropolished.

BioSC™	S	M	L
Maximum number of columns	2 to 6	2 to 6	2 to 6
Productivity range (kg/day)	0.1	3	customized
Typical column diameters (mm)	5 to 26	50 to 150 unlimited	unlimited
Pipe diameter (mm)	3.2	6.35	customized
Flow rate (L/h)	0 - 5	0 - 150	0 - 5000
Standard max operating pressure (bar)	6	6	customized
Dimensions W x H x D (cm)	200 x 100 x 100	200 x 200 x 100	customized
Average weight (kg)	200	700	customized

Software - Chromsoft BioSC™

• On-line buffer dilution
• Linear and step gradient capabilities
• Up to 4 fraction collections
• Up to 8 inlet lines (for load buffers CIP)
• Multiple safety levels (PID)
• PLC controlled with PC user interface
• Fully automated
• iFix user interface
• Validated software compliant with 21 CFR part 11 and GAMP 4
• User-friendly, designed for chromatographers and producers

Options

• SIP
• Design for ATEX zone
• On line/at line monitoring & advanced control customization
• Tankfarm

Benefits and Advantages

Balancing Downstream Productivity with Upstream Titres

With higher titres, tougher competition and increasingly stringent quality and regulatory requirements, the challenge is to align the efficiency of downstream processing with upstream titres. BioSC™ is a unique system that increases the current chromatography resin working capacity by up to two or three-fold. It offers unique features that help to develop the optimum downstream processing to match your upstream.

Improving Productivity and Quality while Cutting Cost

You cannot compromise when it comes to quality and patient safety.
BioSC™ complies with all regulatory and quality requirements with online monitoring.
BioSC™ can cut your cost in half while increasing productivity and quality.
This is done through a smarter use of the resin, lower consumption of buffers and reduced capital expenditure.
BioSC™ ensures the highest quality and safety level of your product.

Industry focused Innovation

For 15 years, Novasep has been innovating to become the leader in process purification.

With the introduction of BioSC™ Sequential Multi-Column Chromatography System, Novasep is addressing three key challenges critical to effective downstream processing:

• Improving productivity
• Cutting purification costs
• Supporting PAT initiatives

The BioSC™ offers significant advances to improve your downstream processing.

Novasep Services

Novasep combines the complementary talents of chemical, electrical and automation engineers as well as chemists to offer its expertise in customized services suited to your expectations.