Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system?
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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 1

How can flexibility and process economics be combined in one LC system?

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 2

Laguna Design Contichrom® lab equipment for superior LC purification

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 3

Which aspects are important for a purification system? Introducing the flexible Contichrom® lab (all-in-one) process capability. Flexibility • Contichrom® allows developing all downstream pro­ ess c modes (batch, SMB, CaptureSMB, multi-column, MCSGP) with one single piece of equipment and easy process conversion Process economics • The MCSGP process increases both purity and yield by 50 % compared to the corresponding batch process • Contichrom® allows rapid automated process development Scalability • Contichrom® allows retention of the developed product profile, yield and purity...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 5

your purification system operate? Flexibility in process development means that based on the purification challenge the best process is chosen with respect to ease, development time Capture step Polish step Very difficult For affinity capture with low dynamic binding ca- pacity having a broad breakthrough curve, Cap- tureSMB is superior to batch. For simple ternary separations, batch processes are the best options if product (red) and impurity (grey) are well sepa- rated. However for difficult ternary separations of overlapping impurities, the MCSGP process is su- perior. The isolation of...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 6

How can affinity capture be faster and more cost effective? Using CaptureSMB®, a twin column cyclic process, with Contichrom® equipment instead of a single column process for Protein A capture steps has sig­ ni­ficant advantages: • Higher loading velocities shortening the transit time for the capture step by 50 % • Due to faster processing, preservation of protein integrity • Optimal use of Protein A resin capacity leading to a resin cost saving of 50 % • Annual Protein-A resin cost savings in production scale of several Mio USD • Easy and robust twin-column equipment design and software...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 7

How can purity and yield be optimized simultaneously? The MCSGP process operates with twin columns instead of one column, whereby the impure side fractions containing product are recycled internally, extracting all product and thereby increasing both yield and purity. The MCSGP process mode is typically operated with the same transit time as a batch chromatography step. A batch derived from a MCSGP process has the same «batch definition» as one from a normal single column batch process. It is a specific quantity of material or API processed in one process or series of processes so that it...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 8

How can impurities be isolated more efficiently? Applications in Discovery and in the isolation of product-related impurities: • Discovery: In shotgun proteomics (bottom-up), due to the complexity of the samples, extensive front-end separation is essential to alleviate the problem of peptide undersampling, to maximize protein identifications and to tackle the vast dynamic range. • The MCSGP process allows selective enrichment of a defined region of the chromatogram (red) • The enriched fraction can be isolated for functional characterization or analyzed directly online using mass...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 9

Does your system provide automated process development? Contichrom® lab equipment and software have been designed to be very user-friendly. The control software helps the user to easily navigate and manage process setup, execution, and reporting. Fast and automated process development • Wizards with graphical user interface for easy method programming • Automated conversion from batch to MCSGP process • Extensive library of pre-defined methods for all standard operations Easy to operate • Intuitive software for operation of batch and MCSGP • Active flow path highlighted in flowsheet •...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 10

The Contichrom® wizard allows switching a batch process to a superior MCSGP process in just three steps: Step 1: Firstly, a non-optimized batch process is developed, the product peak is identified and the batch chromatogram is stored in the database. For conversion of a batch to an MCSGP process, the respective batch Step 2: Using the Contichrom® software wizard, the borders of the product peak (red) are defined by simply dragging bars to define the boundaries. The narrower the boundaries are defined, the purer the isolated product. Then the boundaries of the recycling fractions (blue) are...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 11

How do you combine multifunctionality with a small footprint? Application fields: • Process development: facilitated through flexibility in choosing the right process for a given process challenge • Isolation of product-related impurities: the tedious task of isolating product-related impurities for preclinical / toxicological characterization is considerably facilitated using Contichrom® with MCSGP mode • Preparative product purification: The Contichrom® lab is available in two versions with two different pumps: • Contichrom® lab-10: 0.01–10 mL/min for up to 20 g product /day • Contichrom®...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 12

Multi-functionality with a small footprint • Contichrom® is a preparative liquid chromatography system intended for process screening and development. • Instead of time-consuming Design of Experiments (DoE) for establishing optimized starting conditions, Contichrom® offers a software wizard tool to easily convert a basic batch process to a superior MCSGP process, thus reducing development time for robust and economic processes considerably. • The Contichrom® operating software provides pre-defined methods for standard batch operations and for an intuitive user-friendly operation and data...

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Purification solutions: Contichrom system, How can flexibility and process economics be combined in one LC system? - 13

Contichrom® Technical specifications Main system components: • System configuration: 2-column setup • 1 x binary high pressure gradient pump • 2 x isocratic pumps, 2 x UV detectors • 6 x 6-way 7-port valves, 2 x 2-way 6-port valves • 1 x degasser, 1x pH / conductivity sensor • 1 x computer / monitor / keyboard / mouse • 1 x Contichrom® operating software • 1 x ethernet switch Maximum system pressure: 100 bar Pump description: • double piston pump • biocompatible, titanium inlays • active piston seal wash • flow rate: • Contichrom® lab-10: 0.01– 10 mL/min • Contichrom® prep-100: 1–...

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