WO2021081127A1 - Système et procédés d'identification immuable de produits ou de traitements biologiques dérivés de sources biologiques - Google Patents

Système et procédés d'identification immuable de produits ou de traitements biologiques dérivés de sources biologiques Download PDF

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Publication number
WO2021081127A1
WO2021081127A1 PCT/US2020/056716 US2020056716W WO2021081127A1 WO 2021081127 A1 WO2021081127 A1 WO 2021081127A1 US 2020056716 W US2020056716 W US 2020056716W WO 2021081127 A1 WO2021081127 A1 WO 2021081127A1
Authority
WO
WIPO (PCT)
Prior art keywords
donor
chain
patient
indication
biometric identifiers
Prior art date
Application number
PCT/US2020/056716
Other languages
English (en)
Inventor
Linda Barnes
Original Assignee
X-Cellsystems Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by X-Cellsystems Inc. filed Critical X-Cellsystems Inc.
Publication of WO2021081127A1 publication Critical patent/WO2021081127A1/fr

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients

Definitions

  • HCT/Ps cellular and tissue-based products
  • ATMPs advanced therapy medicinal products
  • cellular starting material is collected from a human donor, processed, modified, then infused for therapeutic effect as a final drug product.
  • Primary cells may be further expanded into working cell banks, gene-edited, cryopreserved, banked, or stored for off-the-shelf access.
  • records must be maintained regarding the donor, the product, and the patient.
  • the process is autologous; i.e. the donor is the same as the patient. Consequently, cellular starting material must be identified to the donor/patient and the finished biopharmaceutical matched exactly to the patient.
  • the process is allogeneic; i.e. the donor is different from the patient.
  • the relationship of the donor to the patient must be known and positively confirmed for safety monitoring or pharmacovigilance. Additionally, uniquely curated donors must be affirmatively identified at each donation, which may occur at separate timepoints and different locations, for purposes of consistency of the process and therapeutic characteristics. Many biological products may result from a single donor over their lifetime; tens of thousands of products may be manufactured, stored, and used for treatment; and a patient may receive biological products from many different donors over a lifetime. .
  • Fig. 1 is a diagram showing an embodiment of the invention
  • Fig. 2 is a flow chart showing an embodiment of the invention.
  • an immutable identification method (100) is comprised of a method to confirm a donor providing cellular material (10), a method to verify a biopharmaceutical product to cellular material (20), and a method to confirm a patient who will receive biopharmaceuticals or derivatives (30).
  • the method to confirm a donor providing cellular material (10) is comprised of associating the cellular material (not shown) with donor (1) biometric identifiers (10A).
  • Biometrics are metrics that relate to human characteristics. Biometric identifiers are distinctive, measurable characteristics used to label and describe individuals.
  • donor (1) biometric identifiers (10A) includes demographic information.
  • the method to confirm a donor providing cellular material (10) is further comprised of identifying the genomic data or laboratory data (10B) of the cellular material.
  • Genomic data and laboratory data (10B) may be obtained through laboratory testing.
  • Genomic data and laboratory data (10B) may include blood phenotyping or other types of point- of-care tests that may allow for rapid verification.
  • the method to verify a biopharmaceutical product to cellular material (20) is comprised of identifying genomic data or laboratory data of the donor (20A) of the biopharmaceutical product.
  • the method to confirm a patient who will receive biopharmaceuticals (30) is comprised of identifying the patient (3) biometric identifiers (30A).
  • patient biometric identifiers (30A) include demographic information.
  • the immutable identification method (100) is further comprised of a method to confirm purity of a biopharmaceutical product (40A).
  • the method to confirm purity of a biopharmaceutical product (40A) is comprised of comparing donor genomic data or laboratory data (10A, 10B) with biopharmaceutical product genomic data or laboratory data, (20A).
  • the immutable identification method (100) is further comprised of a method to confirm donor and patient (50).
  • the method to confirm donor and patient (50) is comprised of comparing donor biometric identifiers (10A) with patient biometric identifiers (30A).
  • the immutable identification method (100) is further comprised of a method confirming the product and to a patient (40B).
  • the method to confirm the product to a patient (40B) is comprised of confirming product (2) genomic verification (20) to patient (3) biometric verification (30A).
  • the present invention may provide for a computer program product embodied in a computer readable medium that, when executing on one or more computers, provides an immutable identification system (200) that allows a plurality of users confirm information related to biopharmaceutical products and/or derivatives.
  • an immutable identification system 200
  • the immutable identification system (200) is comprised of the method to confirm a donor providing cellular material (10), a method to identify collected cellular material (210), and a method to link the donor providing cellular material to the collected cellular material comprised of a chain of identity indication (220).
  • the chain of identity indication (220) may include donor information, laboratory data, label confirmation [DIN/Date], collection ID, amongst others.
  • immutable identification system (200) allows for the collected cellular material (not shown) to be conveyed (230) to a third party for product development or testing (240), primary cell lines (250), working cell lines (260), shipping (280), amongst other uses.
  • a chain of custody indication (320) is created
  • the chain of custody indication may include donor information, laboratory data, label confirmation [Donation Identification Number (“DIN”)/Date], collection ID, amongst others.
  • a chain conformance indication (300) is created when collected cellular material is conveyed (230) for primary cell lines (240) .
  • the chain of conformance (300) may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID.
  • a chain of condition indication (310) is created.
  • the chain of condition (310) may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, amongst others.
  • a chain of purity and potency (360) is created.
  • the chain of purity and potency (310) may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, amongst others.
  • a chain of purity and potency (360) is created.
  • the chain of purity and potency may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, amongst others.
  • a chain of condition (310) is created.
  • the chain of condition (310) may include genomic data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, Bol. No., Tracking No., Time/Date of Shipping, amongst others.
  • a primary cell lines are converted to working cell lines (260), a chain of suitability (350) is created.
  • the chain of suitability (350) may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, amongst others.
  • a chain of purity and potency is created.
  • the chain of purity and potency (360) may include genomic data, laboratory data, specimen label confirmation, label confirmation [DIN/Date], collection ID, cell line batch ID, container ID, amongst others.
  • a chain of identity indicator (330) and a chain of safety indicator (340) are created.
  • the chain of identify indicator (330) confirms that the method to confirm a patient (30) has been established.
  • the chain of safety indicator (340) allows for pharmacovigilance.
  • the chain of safety indicator (340) includes biometric data, genomic data, laboratory data, and patient data. These data create means to independently confirm the identity of the source donor and the receiving patient at the point of treatment.
  • immutable identification system (200) uses smart contracts which generate each chain of identity (220), chain of custody (320, 380), chain of conformance (300), chain of condition (310), chain of stability (350), chain of purity & potency (360), chain of identity (330) and chain of safety (340) through any method known for providing self-sovereign identity (SSI) certificates.
  • donor, cellular material, patient data and generated certificates are maintained over a distributed ledger and a decentralized database system. This permits independent quality control, confluence of data studies, and good pharmacovigilance actions that look back to the originating biological source, regardless of timepoint, 5 manufacturing system, or location, and affirmatively identify recipients for contact tracing purposes over time.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Public Health (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Procédé et systèmes de contrôle de qualité indépendant, de convergence d'études de données et de bonnes actions de pharmacovigilance qui considèrent rétrospectivement la source biologique d'origine, indépendamment du point temporel, du système de fabrication ou de l'emplacement, et identifient de manière affirmative des destinataires à des fins de traçage de contact dans le temps.
PCT/US2020/056716 2019-10-21 2020-10-21 Système et procédés d'identification immuable de produits ou de traitements biologiques dérivés de sources biologiques WO2021081127A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962923689P 2019-10-21 2019-10-21
US62/923,689 2019-10-21

Publications (1)

Publication Number Publication Date
WO2021081127A1 true WO2021081127A1 (fr) 2021-04-29

Family

ID=75620206

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2020/056716 WO2021081127A1 (fr) 2019-10-21 2020-10-21 Système et procédés d'identification immuable de produits ou de traitements biologiques dérivés de sources biologiques

Country Status (1)

Country Link
WO (1) WO2021081127A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167900A1 (en) * 2006-12-29 2008-07-10 Medrad, Inc. Biometric characterization of agents and patient safety in biological injection or administration
US20170199977A1 (en) * 2008-02-26 2017-07-13 Purdue Research Foundation Method for patient genotyping

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080167900A1 (en) * 2006-12-29 2008-07-10 Medrad, Inc. Biometric characterization of agents and patient safety in biological injection or administration
US20170199977A1 (en) * 2008-02-26 2017-07-13 Purdue Research Foundation Method for patient genotyping

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