Episode 9: Streamlining the cell and gene therapy manufacturing

Delivering Personalized Therapies: Streamlining the Supply Chain for a New Generation of Treatments

In this episode, we speak with Amy DuRoss, Co-Founder and Chief Executive Officer of Vineti, about the challenges facing "just-in-time" manufacturing and delivery of personalized therapies—and the solutions her digital startup provides.

 

According to Amy DuRoss, the COVID-19 vaccine distribution has exposed existing deficiencies in the entire pharmaceutical supply chain. This situation echoes, albeit on a far smaller scale, the distribution complexities of delivering cell and gene therapies (CGT). Unlike more traditional treatments, CGT requires the extraction of live cells from a patient or donor to then be delivered to a manufacturer and make it back to the patient in a timely manner. Her company Vineti "introduces a new level of fidelity, control, and transparency" into the personalized drug delivery process, streamlining CGT distribution through a novel digital orchestration platform. Based on an astute understanding of the behavior of care providers, specialized couriers and CGT manufacturers, her company has developed a software infrastructure that supports this exponentially complex delivery process. By facilitating Good Manufacturing Principles for all required stakeholders in the advanced therapy process, the Vineti platform ensures regulatory compliance and maintains both Chain of Identity and Chain of Custody from cell collection to manufacturer and back to the patient.

 

Curious to Know More?

Take a listen to this episode of A View On: Streamlining Cell and Gene Therapy Manufacturing to learn more about Vineti. At the end of the discussion, as a bonus for our listeners, Amy DuRoss offers insight into some of the difficulties encountered in the COVID vaccine rollout, and how it parallels the complexity of the supply chain for CGT.

 

KEY TERMS:

 

Personalized medicine and therapies, such as cell and gene therapies (CGT), treat patients on a much more individualized basis. They require an unprecedented level of automation and navigation because the materials used to prepare the end product are raw cells originating from a donor or a patient.

Good Manufacturing Principles (or Practices), GMP for short, are practices that ensure adherence to the guidelines put forth by regulatory agencies. They apply to any manufacturing industry but reach an unparalleled level of complexity in CGT production due to the implication of health care providers in the cell extraction and donor matching processes.

A digital orchestration platform such as Vineti's uses the power of data management and user experience design to organize and execute an effective supply chain system in the face of exceptional complexity and strict regulations.

Chains of Identity and Custody in the pharmaceutical supply chain are the cornerstones of regulatory compliance, whereby each step in the process and each individual involved is transparently identifiable in order to reduce the risk of contamination and to eliminate fraud. With CGT production, the process of extracting the raw materials for the treatment directly from the patient or donor multiplies the Chains of Identity and Custody, exponentially increasing the supply chain complexity.