Patient-Specific Therapeutic Tracking With Multi-Factor Sample Verification

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Solution Overview

Problem

Existing tracking systems for patient-specific therapeutics are prone to mix-ups during the processing and administration phases, leading to potential adverse effects, treatment failures, and exposure to diseases, despite the use of extrinsic labeling and blockchain technologies.

Innovation Solution

A system utilizing a combination of intrinsic and extrinsic data linked through a sample tracking chain, such as a blockchain, to electronically track and verify biological samples and therapeutics, ensuring multi-factor authentication and validation at each stage from sample procurement to administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If extrinsic labeling (bar codes, patient names) is used to track biological samples, then sample identification is enabled, but mix-ups and processing errors still occur during manufacturing and administration

Engineering Contradiction:

Improvesample identification accuracyVSAvoidsample identity verification

Core Design Contradiction:

ReliabilityVSLoss of information

Solution Approach 1:

The patent creates a digital copy (blockchain record) of the biological sample's identity and tracking information that persists throughout the entire lifecycle. This digital twin serves as a verification mechanism that can be checked at any point without altering the original sample or requiring physical labels that can be misplaced or misread.

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The blockchain acts as an intermediary layer between the biological sample and the tracking system. Instead of directly labeling the sample with extrinsic information that can be confused or lost, the system uses blockchain records to mediate verification, ensuring that sample identity is confirmed through cryptographic proof rather than human-readable labels.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If manual processing and tagging of samples is performed, then sample tracking is implemented, but significant processing time is required and mix-ups remain possible

Engineering Contradiction:

Improvesample tracking accuracyVSAvoidmanual processing time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary actions by automatically generating and recording the sample's digital identity in the blockchain at the moment of collection. This initial blockchain record contains all necessary verification data, eliminating the need for subsequent manual tagging and reducing processing time at later stages while maintaining tracking accuracy.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent replaces manual mechanical processes (handwriting labels, physical tagging, visual verification) with automated digital processes. Blockchain technology and digital verification systems substitute for human operators, dramatically reducing manual processing time while increasing reliability through cryptographic verification.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If blockchain technology is used for supply chain tracking, then transparency and traceability are improved, but device and system complexity increases

Engineering Contradiction:

Improvetracking transparencyVSAvoidblockchain system implementation

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the blockchain implementation into distinct functional layers: a simplified interface layer for users, a verification layer for validation, and the blockchain ledger layer for data storage. This segmentation allows the complex blockchain technology to be deployed without requiring the entire system to become equally complex, as each layer handles specific functions independently.

Inventive Principle:

Principle #1Segmentation

4Reliability

If multiple validation checks are performed at each stage, then mix-ups are reduced, but processing time and operational complexity increase

Engineering Contradiction:

Improvetherapeutic-patient matching accuracyVSAvoidworkflow simplicity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The blockchain system performs self-service validation by automatically verifying sample identity and tracking information through cryptographic proof. The system validates its own data integrity without requiring external verification steps, reducing operational complexity while maintaining multiple validation checks. The immutable ledger structure inherently prevents mix-ups without adding manual verification burden.

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS12580056B2Production and delivery tracking and sample verification of patient-specific therapeutics

Publication Date: 2026.03.17 NANTCELL INC

AI summary

Systems and methods for tracking biological samples are presented. Intrinsic and extrinsic biological sample data and/or intrinsic and extrinsic patient data may be used to label a biological sample obtained at a point-of-care facility, which may be sent to a processing facility, wherein the labeled biological sample undergoes analysis and/or processing into a labeled therapeutic. The labeled therapeutic is delivered back to the point-of-care facility, wherein the labeled therapeutic is tested for the presence of the additives prior to administration to a patient. Multi-factor validation is performed, including validating the identity of the patient to a container, validating the identity of the labeled biological sample/therapeutic to the container, and thus, validating the identity of the labeled therapeutic to the patient. The entire life cycle of a biological sample used to generate a personalized therapeutic is validated, and ensures that mix-ups or errors in administration are reduced or eliminated.