Biological Substance Traceability in Continuous Manufacturing
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Solution Overview
Problem
Continuous manufacturing of biological substances faces challenges in traceability, leading to difficulties in identifying and isolating defective products, which can result in complete process shutdowns, product rejection, and increased costs.
Innovation Solution
A method and system for continuous manufacturing of biological substances using multiple bioreactors and collectors, where each cell culture and harvest cycle produces a sub-batch of the biological substance, allowing for separate collection and downstream processing, thereby enhancing traceability and reducing residence time overlap between sub-batches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If continuous manufacturing is used to improve production efficiency, then productivity increases, but traceability of intermediate and final products deteriorates
Solution Approach 1:
The continuous manufacturing process is segmented into discrete harvest cycles, where each cycle produces a separately identifiable sub-batch. This segmentation allows traceability to be maintained while preserving the continuous nature of the process, as each sub-batch can be tracked through downstream processing independently.
Solution Approach 2:
An intermediary tracking system is introduced that links sub-batches from upstream harvest cycles to their corresponding final products through downstream processing. This intermediary mechanism enables traceability without interrupting the continuous flow of material through the manufacturing process.
2Loss of time
If continuous manufacturing is used to reduce residence time, then product degradation decreases, but ability to isolate defective products worsens
Solution Approach 1:
By segmenting the continuous process into discrete harvest cycles with separate collectors, defective sub-batches can be identified and isolated at specific points in the process. This maintains the short residence time benefits of continuous manufacturing while enabling targeted removal of defective material without complete process shutdown.
Solution Approach 2:
Quality control is applied locally to specific sub-batches rather than requiring whole-process interruption. When a defective sub-batch is identified, only that specific portion is isolated and rejected, while the rest of the continuous process continues uninterrupted, maintaining both speed and reliability.
3Loss of information
If batch manufacturing is used to maintain traceability, then product identification improves, but production efficiency deteriorates
Solution Approach 1:
The batch process is reimagined with segmentation of harvest cycles into separately collectible sub-batches. This allows batch-level traceability and identification to be maintained while the overall process operates continuously, eliminating the efficiency losses associated with complete batch interruptions.
Solution Approach 2:
Sub-batches are preliminarily collected and identified during the harvest phase before entering downstream processing. This preliminary action establishes traceability early in the process, allowing continuous operation to proceed without later interruptions for identification or sorting.
Data Source
AI summary
The invention concerns a method and system for the continuous manufacturing of a biological substance with process traceability. The method and system involves performing a number of cell culture and harvest cycles using a bioreactor for producing a batch of the biological substance, with each cycle producing a sub-batch of the biological substance. For process traceability in consecutive cell culture and harvest cycles the produced sub-batches of biological substance are first collected in separate collectors before being continuously directed from each collector through downstream processing means for downstream processing of the biological substance to at least purify the biological substance into at least one lot containing purified biological substance.