Modular Biopharma Suites With Pre-Validated Flow Connections

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Solution Overview

Problem

Existing biopharmaceutical production facilities face high costs and geographic limitations due to the need for customized infrastructure and extensive personnel training, especially at higher biosafety levels, limiting flexibility and efficiency in expanding production volume.

Innovation Solution

A volume tailorable manufacturing system with a central spine supply system and discrete multi-product suites, each with independent inlet and outlet pairs, allowing for flexible expansion and contraction of production capacity while maintaining biosafety level compliance, using a control facility to manage unidirectional flow and pre-validation of connections.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If customized production facilities are built for higher biosafety levels, then biosafety compliance is achieved, but production cost and facility establishment cost increase significantly

Engineering Contradiction:

Improvebiosafety complianceVSAvoidproduction cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The production facility is divided into modular suites that can be independently configured and connected. Each suite is a self-contained module with standardized interfaces, allowing the facility to be assembled from pre-fabricated units rather than custom-built structures, thereby reducing costs while maintaining biosafety compliance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The facility design allows dynamic reconfiguration of modular suites through standardized connection interfaces. Suites can be added, removed, or repositioned to adapt to changing production needs without requiring complete facility reconstruction, enabling cost-effective scaling and flexibility.

Inventive Principle:

Principle #15Dynamics

2Reliability

If extensive personnel training is provided for higher biosafety levels, then biosafety compliance is achieved, but production cost increases

Engineering Contradiction:

Improvebiosafety complianceVSAvoidproduction cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

By segmenting the facility into standardized modular suites with consistent biosafety features, the training requirement is reduced to a repeatable set of procedures for each module type rather than custom training for each facility, lowering overall training costs while maintaining compliance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The standardized modular design allows replication of proven biosafety configurations across multiple suites. Once a suite design is validated and trained upon, identical copies can be deployed elsewhere in the facility with minimal additional training, reducing the burden of extensive continuous training.

Inventive Principle:

Principle #26Copying

3Productivity

If production facility is expanded to increase production volume, then productivity is improved, but time and cost for tailoring production infrastructure increase

Engineering Contradiction:

Improveproduction volumeVSAvoidtime for facility expansion

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

The facility is composed of pre-fabricated modular suites that can be independently manufactured and then assembled on-site. This segmentation allows parallel development of multiple modules and reduces on-site construction time, enabling faster expansion to increase production volume.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Modular suites are pre-configured, pre-tested, and pre-validated in a controlled environment before deployment. This preliminary preparation ensures that when suites are installed and connected in the final facility, they require minimal on-site customization and commissioning, significantly reducing the time needed for facility expansion.

Inventive Principle:

Principle #10Preliminary action

4Productivity

If geographic clustering of production facilities is implemented, then staffing and supply efficiency are improved, but geographic limitations remain due to facility customization requirements

Engineering Contradiction:

Improvestaffing and supply efficiencyVSAvoidgeographic expansion flexibility

Core Design Contradiction:

ProductivityVSAdaptability or versatility

Solution Approach 1:

The modular suites are designed with universal standardized interfaces and configurations that can be deployed in any location. This universality allows the same proven design to be replicated across different geographic sites, enabling geographic clustering for operational efficiency while maintaining the flexibility to expand to new locations when needed.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentEP3710154B1Method and system for manufacturing of biopharmaceutical products

Publication Date: 2025.12.31 CYTIVA SWEDEN AB

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Figure 2c

AI summary

The present disclosure relates to a volume tailorable manufacturing system for quality assured manufacturing of biosafety level classified biopharmaceutical products and a method for tailoring a production volume capability of a manufacturing system. The volume tailorable manufacturing system comprises one or more multi-product suites and a control facility configured to control a unidirectional flow in a circulation system of the one or more multi-product suites. The circulation system is configured to interconnect the one or more multi-product suites and comprises separated supply and return systems. The supply system comprising at least one inlet, the return system comprising at least one outlet that is paired with the inlet and provided at a spatially predetermined position from the inlet, and each inlet/outlet pair comprises a seal when not connected to an adjacent multi-product suite.