Single-Use Bioreactor Subchambers for Sterile Processing

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Solution Overview

Problem

Current biopharmaceutical manufacturing requires large-scale facilities and high upfront costs, making it difficult to deploy cost-effective and safe systems for personalized medicine and small-scale drug production, especially in settings that need sterile environments.

Innovation Solution

A modular system of single-use containers with subchambers that can perform upstream and downstream processing of biological materials, allowing for customizable and sterile processing without the need for large facilities, using a network of single-use chambers connected via aseptic connectors and supporting equipment modules.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If large-scale manufacturing facilities and equipment are used, then sterile environment and product safety are ensured, but upfront costs and infrastructure requirements increase significantly

Engineering Contradiction:
Improvesterile environmentVSAvoidfacility scale
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The manufacturing system is divided into multiple independent single-use bioreactors, each capable of operating autonomously in its own sterile environment. This segmentation allows small-scale facilities to achieve the same sterile reliability as large-scale facilities by isolating each processing unit, eliminating the need for large centralized cleanrooms while maintaining product safety.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs disposable single-use bioreactors that are pre-sterilized and sealed. These single-use containers eliminate the need for expensive, complex sterilization infrastructure and large-scale cleanrooms, as each bioreactor maintains its own sterile environment independently. After use, the entire bioreactor is discarded, avoiding the need for costly cleaning and validation procedures associated with reusable large-scale equipment.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Productivity

If large-scale manufacturing facilities are used, then adequate processing capacity is achieved, but cost-effectiveness decreases

Engineering Contradiction:
Improveprocessing capacityVSAvoidcost-effectiveness
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

Multiple single-use bioreactors can be operated in parallel to achieve the required processing capacity. This modular approach allows facilities to scale productivity by simply adding more independent units rather than investing in expensive large-scale facilities, making the system cost-effective while maintaining adequate throughput for personalized medicine production.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system allows dynamic configuration and scaling of bioreactor networks. Facilities can start with a small number of bioreactors and gradually add more units as demand increases, avoiding the need for large upfront investments in oversized facilities. This dynamic scalability ensures cost-effectiveness by matching processing capacity to actual production needs.

Inventive Principle:
Principle #15Dynamics

3Reliability

If conventional production systems are used, then sterile manufacturing is achieved, but flexibility for personalized medicine decreases

Engineering Contradiction:
Improvesterile manufacturingVSAvoidproduction flexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

Each single-use bioreactor is an independent, self-contained sterile unit that can be programmed and operated autonomously. This segmentation allows each unit to be customized for specific personalized medicine applications without affecting other units, providing high flexibility while maintaining sterile manufacturing. Different bioreactors can handle different patient-specific products simultaneously, each with its own controlled parameters and protocols.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentUS11359172B2Upstream and downstream processing within single-use containers
Publication Date: 2022.06.14 SARTORIUS STEDIM BIOTECH GMBH
  • US11359172B2 patent drawing
  • US11359172B2 patent drawing
  • US11359172B2 patent drawing

AI summary

A single-use chamber comprising a primary subchamber containing at least one primary component configured to perform an operation comprising at least one of generation and handling of a biological material; and a secondary subchamber containing at least one of a connection to equipment external to the single-use chamber and a secondary component, wherein the external equipment and the secondary component are configured to support the operation of the at least one primary component; wherein the primary subchamber and the secondary subchamber are configured to be connected to each other so that the at least one primary component is operatively coupled to at least one of the connection and the secondary component.