Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT

Managing the Chain of Custody and Identity for Regenerative Medicine Products.

By: Daniel R. Matlis, President

According to FDA Commissioner Scott Gottlieb, M.D.  “We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”

The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.

In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment.  In gene therapy products, cells removed from the patient become the raw material.  They are then genetically modified and returned to the patient as the “finished product”.

When manufacturing regenerative medicine products with a Lot Size of YOU, a secure, traceable Chain of Custody and Chain of Identity is paramount to ensure the safety and quality of the finished products.

FDA has already approved a number of gene based therapies.  An important recent approval is Kite Pharma’s Yescarta, a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma. 

A digital “platform of record” for individualized therapies

To support the delivery of Yescarta, Kite Pharma partnered with Vineti to develop Best-In-Class Logistics and Data Analytics Software for Engineered T-cell Therapies at Commercial Scale.

Axendia was recently briefed by Vineti to learn about the firm’s platform specifically built to move patient-based personalized therapies into mainstream medicine at scale.

“Vineti provides a digital “platform of record” for individualized therapies,” said Amy DuRoss, Co-Founder and CEO at Vineti. “Our technology makes the rapidly growing field of personalized therapies simpler, safer, and more accessible for patients, clinicians, and therapy developers. We help enable the delivery of transformative therapies for cancer and serious genetic disorders,” she added.

Producing and delivering a new generation of personalized medicines at mass scale is a complex and risky challenge. Other types of personalized therapies, such as donor-based allogeneic therapies or personalized cancer vaccines, present their own challenges in terms of patient matching, data and sample tracking, and ultimately returning the right therapy to the right patient.

In all of these types of individualized therapies, patients are the raw material for the medicine. “This new ecosystem of patient-based therapies offers huge promise — and new challenges in terms of quality, tracking, and safely,” commented Marc Puich, Vice President of Business Development. “Vineti wants to help open up patient access to all these therapies, as well as others to come,” he added.

To support this goal, Vineti built the first cloud-based platform specifically built to safely, simply, and efficiently move patient-based personalized therapies into mainstream medicine at scale.

“Vineti really benefits from our hybrid, deeply-experienced team,” said DuRoss. “We have leaders in cell therapy operations, enterprise software, biopharma systems, and the life sciences, all working together on behalf of our pharmaceutical partners. We’re all on a mission to open up patient access to these transformative therapies.”

Vineti provides a single end-to-end platform that provides treatment ordering and scheduling, supply chain orchestration, chain of identity resource planning, regulatory compliance, reimbursement, and customer experience.


The solution delivers secure, traceable chain of custody and chain of identity at every stage through a configurable, cloud-based, secure, scalable enterprise software. This approach enables ecosystem integration to align and orchestrate all aspects of the patient’s therapy journey.


Regenerative medicine offers transformative promise for patients. While the FDA has approved products in this category, many of these technologies are in early stages of development. The rapid growth, dynamism and complexity in this this field presents unique challenges to researchers, manufacturer’s health care providers and the FDA.

A digital “platform of record” that supports chain of custody and chain of identity across the ecosystem is paramount to ensure the safety, quality, and efficacy of these medical products so that patients can benefit from these novel therapies.


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