Modular Bioprocessing System for Automated Cell Isolation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing bioprocessing systems for manufacturing CAR T cells are complex, costly, inflexible, and prone to contamination due to high human touchpoints, which hampers efficiency and adaptability.

Innovation Solution

A bioprocessing system comprising modular components such as a centrifugal processing chamber, heating/cooling mixing chamber, and magnetic cell isolation module, utilizing disposable kits and automated processes to streamline cell isolation, activation, genetic modification, and expansion, allowing for parallel processing and reduced contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated bioprocessing systems are implemented, then productivity and manufacturing throughput are improved, but device complexity and cost increase

Engineering Contradiction:

Improvemanufacturing throughputVSAvoidsystem complexity

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The bioprocessing system is divided into separate functional modules: a centrifugal processing chamber for cell separation, a heating/cooling mixing chamber for cell activation and transduction, and a magnetic cell isolation module for purified cell collection. Each module performs a specific function and can be independently operated or combined, allowing high-throughput automated processing while managing system complexity through functional decomposition

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The centrifugal processing chamber serves multiple functions: initial cell separation from blood, concentration of cell populations, and preparation for subsequent processing steps. The heating/cooling mixing chamber provides both thermal control and mixing functions for cell activation and transduction processes. This multi-functionality increases productivity without proportionally increasing overall system complexity

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Reliability

If modular disposable kits are used, then reliability and contamination prevention are improved, but ease of manufacture decreases

Engineering Contradiction:

Improvecontamination preventionVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The system employs disposable single-use kits containing pre-filled bags and cartridges for cell processing. These disposable components eliminate cross-contamination risks between batches and patients, ensure sterile conditions throughout the automated process, and can be easily manufactured and sterilized independently of the expensive automated equipment, thereby maintaining reliability while managing manufacturing complexity

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

3Manufacturing precision

If magnetic cell isolation is implemented, then manufacturing precision and cell purity are improved, but use of energy increases

Engineering Contradiction:

Improvecell isolation purityVSAvoidmagnetic field energy consumption

Core Design Contradiction:

Manufacturing precisionVSUse of energy by moving object

Solution Approach 1:

The system replaces mechanical filtration and centrifugation methods with magnetic field-based cell isolation. Magnetic beads conjugated to antibodies specifically bind target cells, and the magnetic field rapidly separates these bound cells from the remaining population. This provides superior cell isolation purity compared to mechanical methods while the energy consumption is limited to the magnetic field generation, which is more efficient than continuous mechanical agitation or high-speed centrifugation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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

The system enhances efficiency, flexibility, and reduces contamination risks by automating key processes, enabling simultaneous expansion of multiple cell populations and improving overall manufacturing throughput while maintaining regulatory compliance.

Implementation Method 1

The magnetic cell isolation device is configured to generate a magnetic field for retaining bead-bound cells in the magnetic cell isolation holder when receive in the slot

Methodology Applied

Scientific EffectMagnetic field: Magnetic Field

Implementation Method 2

a separation chamber configured for use with a centrifugal processing chamber of the cell processing device

Methodology Applied

Scientific EffectCentrifugal force: Centrifugal Force

Data Source

PatentUS20240010966A1Systems and methods for cell enrichment, isolation and formulation

Publication Date: 2024.01.11 GLOBAL LIFE SCIENCES SOLUTIONS USA LLC

AI summary

An apparatus for magnetic cell isolation includes a base, a stopcock manifold interface located on the base and configured to receive a stopcock manifold of a cell processing kit, a magnetic field generator located within the base, and a slot formed in the base, the slot configured to removably receive a magnetic cell isolation holder. The magnetic field generator is movable into and out of engagement with the magnetic cell isolation holder.