Industry Resources
and Information

Elevating industry expertise with the latest insights in personalized therapies

As part of our mission to open up access to advanced therapies, Vineti works hard on collective insight sharing for industry growth. We're also contributing members of leading organizations such as the Alliance for Regenerative Medicine, the International Society for Cell and Gene Therapy, and the Standards Coordinating Body. Please access and share our content, or contact us to collaborate on thought leadership.

Vineti snapshots

Flyers, checklists, and shorter articles, available as downloadable PDFs (you'll also find in-depth pieces on our Reports page)

Terminology to know

Autologous Cell and Gene Therapy

Therapy obtained from the same individual from which the raw material is sourced. In the case of cell and gene therapies, the cells or tissue used in the therapy are extracted from the patient, undergo some sort of manufacturing process outside the body and then are re-infused or implanted back into the original patient as “drug product.” FDA definition: The implantation, transplantation, infusion, or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered (FDA Reg: 21 CFR 1271.3)


Allogeneic Cell and Gene Therapy

The cells or tissue used in the therapy are extracted from a donor (other than the recipient patient), undergo some sort of manufacturing process outside the body and then are infused or implanted into a patient (different from the donor) as "drug product."


Xenogenic Cell and Gene Therapy

Cells or tissue sourced from a different species than that of the intended recipient.


Advanced Therapy Medicinal Products (ATMPs)

Medicinal products for human use that are based on cells, tissue, or genes.


Bone Marrow Aspiration

A procedure where a some of the soft, spongy tissue found inside bones is removed in liquid form via a needle for further testing and use. Bone marrow helps form white/red blood cells and platelets (source of lymphocytes).


Blood Collection – Whole Blood

Whole blood is removed from the patient where the desired cells for treatment are procured from the whole blood during the subsequent manufacturing process.


Blood Collection – Apheresis

Removing whole blood from the patient, separating the blood into components via centrifugation, withdrawing desired components, then reinfusing remaining blood components back into the patient. Leukapheresis is the apheresis process specifically related to collecting white blood cells.

Traceability

The ability to verify the origin, history, location, and application of human cells and tissues used in autologous and allogeneic cell therapies.


Chain of Custody (COC)

Permanent data capture of the “who, what, when, and where” from the start of tissue and/or cell collection through to product administration. The data identifies the staff that handled the product, actions performed by those staff, and the location/date/time of those actions.


Chain of Identity (COI)

The permanent and transparent association of an autologous donor’s unique identifiers to their tissue and/or cells from order through collection, manufacturing, administration, and post-treatment monitoring.


Chain of Condition

Permanent data capture from the start of tissue and/or cell collection through to infusion that tracks temperature and other key variables essential to the quality and viability of the cells and finished product.


Look Forward, Look Back

A term used most commonly in allogeneic cell and gene therapies. It is the ability to use traceability records (COI, COC, etc.) to “look back” to a donor, their cells, and the product journey of their cells should any issues arise with the drug product recipient. Conversely, "look forward" is the ability to trace or identify the recipients who received drug product from a particular donor’s cells in the case that the drug product recipient should be made aware of information about the donor, their cells, or the drug product made from their donation.


Third Party Logistics (3PL)

Third party logistics provider to whom fulfillment services are outsourced. Involved in transportation and warehousing (if applicable) of therapeutic product for transfer between clinical, manufacturing, and storage sites. Often provide additional integrated services critical to supply chain delivery such as managing cold storage shippers.


Single European Code (SEC) – Labeling

A unique identifier required by the European Union to support traceability of human tissues and cells. The SEC consists of two parts, a donation identification sequence, essentially indicating the origin of the tissue or cells, and a product identification sequence, essentially classifying the type of tissue or cells.


ISBT 128 – Labeling

The global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). Provides international consistency to support the transfer, traceability, and transfusion/transplantation of blood, cells, tissues, and organs.

ICCBBA, the international standards organization responsible for the management and development of the ISBT 128 Standard, is a not-for-profit nongovernmental organization in official relations with the World Health Organization (WHO).

API

The Application Programming Interface (API) allows two software programs to communicate with each other. It is a set of commands, functions, protocols, and objects that programmers can use to create software or interact with an external system. It provides developers with standard commands for performing common operations so they do not have to write the code from scratch.


User Requirements Specification (URS)

Document that defines what the user requires the system to do (intended use). The URS serves as the functional scope of the system and provides enough detail to drive Performance Qualification and User Acceptance Testing coverage and FRS development.


Functional Requirement Specification (FRS)

Document that defines how the system should operate as well as what functions and facilities are provided to meet user requirements as outlined in the URS. Provides enough detail to define clear criteria for Operational Qualification testing and drive DS and software development.


Design Specification (DS)

Defines how system functions are customized to meet specific client requirements. Collects and documents design details for solution delivery and change control.


Configuration Specification

Software documentation that defines how the system functions are configured to meet user requirements. Captures the specific values of configurable settings to deliver the required functionality.


Computer System Validation (CSV)

The process of ensuring and documenting that an e-system deployed to manage any cGxP process will consistently meet its predetermined specifications and quality attributes. Verification that it is doing what it should be doing and produces reliable results. Ensures that the electronic system (including records and signatures) are trustworthy, reliable, and compatible with FDA procedures AND are verifiable and traceable.


GAMP®5 or Good Automated Manufacturing Practice

GAMP5 provides a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity. Categorizing the system helps guide the writing of system documentation (including specifications and test scripts and everything in between). The risk-based approach advocated is in line with the application of the European EMA and US FDA regulations governing computer system validation, Annex 11 and 21 CFR Part 11, respectively.

This document is published by an industry trade group called the International Society for Pharmaceutical Engineering (ISPE) based on input from pharmaceutical industry professionals.


SAML-based Single Sign On (SSO)

Security Assertion Markup Language (SAML) is a standard protocol for web browser Single Sign-On (SSO) using secure tokens. SAML completely eliminates all passwords and instead uses standard cryptography and digital signatures to pass a secure sign-in token from an identity provider to a SaaS application.

Software System Acronyms

Any of these systems can be integrated with the Vineti platform.

MDM


Master Data Management

MDM


Master Data Management

CM


Case Management

CM


Case Management

EHR


Electronic Health Record

EHR


Electronic Health Record

CRM


Customer Relationship Management

CRM


Customer Relationship Management

MES


Manufacturing Execution System

MES


Manufacturing Execution System

EBR


Electronic Batch Record

EBR


Electronic Batch Record

MRP


Materials Requirements Planning

MRP


Materials Requirements Planning

ERP


Enterprise Resource Planning

ERP


Enterprise Resource Planning

QMS


Quality Management System (including "doc control")

QMS


Quality Management System (including "doc control")

LIMS


Laboratory Information Management System

LIMS


Laboratory Information Management System

LMS


Learning Management System

LMS


Learning Management System

Requirements Gathering, Documenting,
Testing, and Verification Process

 

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