Stackable Chromatographic Cassette Planar Adsorptive Bed
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Solution Overview
Problem
Conventional chromatographic devices are not linearly scalable, requiring significant design and geometry alterations as device size increases, leading to uncertainties and risks in pharmaceutical manufacturing processes, and are limited in operating at high velocities and pressures with softer beads, which affects productivity and purity of monoclonal antibodies.
Innovation Solution
The development of stackable chromatographic cassettes with a planar, self-supporting adsorptive bed that allows for higher flow rates and pressures, using compressible or semi-compressible media, enabling operation at velocities exceeding 500 cm/hr with residence times under one minute and achieving higher productivity with smaller beads.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional columns are used with softer beads (agarose, PMMA), then bead flexibility and biocompatibility are improved, but operating velocity is limited to below 400 cm/hr
Solution Approach 1:
The patent transitions from conventional three-dimensional packed beds to a two-dimensional planar adsorptive bed configuration. This dimensional change allows softer beads to be supported in a planar arrangement that maintains their flexibility and biocompatibility while enabling higher flow rates and velocities exceeding 500 cm/hr, resolving the contradiction between bead softness and operating speed.
Solution Approach 2:
The patent changes the geometric parameters of the adsorptive bed from a three-dimensional packed structure to a two-dimensional planar structure. This parameter change in bed configuration allows softer beads to operate at higher velocities without voiding or channeling, as the planar structure provides adequate support while maintaining bead integrity and flexibility.
2Productivity
If device size increases for manufacturing scale-up, then production capacity is improved, but design and geometry alterations are required leading to uncertainties
Solution Approach 1:
The patent divides the chromatographic system into modular planar adsorptive bed units that can be scaled independently. Each planar module maintains the same design and geometry, allowing for straightforward scale-up from laboratory to manufacturing scale without requiring design alterations, thus resolving the contradiction between production capacity and device complexity.
Solution Approach 2:
The planar adsorptive bed design serves multiple functions across different scale levels. The same planar geometry and configuration work effectively from small-scale laboratory experiments to large-scale manufacturing, providing universal applicability without requiring scale-specific design modifications, thereby eliminating uncertainties associated with scale-up.
3Productivity
If flow rate and pressure are increased to improve productivity, then residence time is reduced, but bed voiding and pressure drop increase
Solution Approach 1:
By transitioning to a two-dimensional planar adsorptive bed, the patent eliminates the three-dimensional voiding problem that occurs in conventional packed beds at high flow rates. The planar configuration provides continuous support across the flow path, allowing high flow rates and pressures to be applied without causing bed voiding or channeling, thus maintaining bed stability while improving productivity.
Solution Approach 2:
The patent changes the structural parameters of the adsorptive bed from a three-dimensional packed structure with interstitial spaces to a two-dimensional planar structure with distributed support points. This parameter change allows the bed to withstand high flow rates and pressures without collapsing or voiding, as the planar geometry distributes mechanical stress evenly across the bed structure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This solution enables linear scalability, increased productivity, and reduced residence times, allowing for efficient separation and purification of pharmaceuticals across various manufacturing scales without altering processing conditions, and supports the use of softer beads that were previously impractical at high velocities.
Implementation Method 1
chromatography is a general separation technique that relies on the relative affinity or distribution of the molecules of interest between a stationary phase and a mobile phase for molecular separation. The stationary phase typically comprises a porous media imbibed with solvent. The mobile phase comprises a solvent, which can be aqueous or organic, that flows through the interstitial space that exists between the spaces occupied by the stationary phase.
Data Source
AI summary
A hyper-productive chromatography technique includes providing a scalable and stackable chromatographic cassette, loading a sample to be processed, operating the scalable chromatographic cassette having an adsorptive chromatographic bed having a volume greater than 0.5 liter by establishing a flow at a linear velocity greater than 500 cm/hr with a residence time of the loading step of less than one minute.