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Controlling Complexity [Not Cost] of Advanced Therapy Supply Chain

Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex.  Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost.  However, the biggest cost within the supply chain is caused by its complexity.  In this blog we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

Topic: Cell Therapy Solutions, Content: Blog

Importance of Early Planning for Cell Therapy Clinical Trials

As discussed in previous blog articles, early planning is critical, both for cell therapy clinical trials and commercial-scale operations. By addressing how activities will be managed early on, it can minimize risk and cost, and optimize downstream processes. However, oftentimes clients are unsure of which components are critical to address early on.

Topic: Cell Therapy Solutions, Content: Blog

CRISPR-Cas9 Off-Target Effects

In our previous blogs on cell therapy solutions, we summarized the CRISPR-Cas (Clustered, Regularly Interspersed, Short Palindromic Repeats) system as a remarkable tool for greatly simplifying gene manipulation (insertions, deletions, development of knock-in and knock-out animal models).  Also described were ways to study epigenetic processes by ‘borrowing’ the Cas9 nuclease from the CRISPR system to pair with histone acetylation domains for induction of acetylation at specific sites.  For instance, one application of this capability could be applied in gene therapy, whereby incorporation of epigenetic changes could achieve gene silencing of abnormally activated genes, or by controlling stem cell differentiation.

Topic: Cell Therapy Solutions, Content: Blog

Reducing Cost within Advanced Therapy Clinical Trials

The challenge for advanced therapy companies is that they need to develop a supply chain that delivers their therapy, at scale, without adding significantly to the cost of goods sold (COGS). In this case study we’ll demonstrate how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data. By trusting our team of experts to deliver a robust global storage and logistics strategy, the clinical trial ran more efficiently and provided the Sponsor company with the confidence to focus on other high value activities.

Topic: Cell Therapy Solutions, Topic: Cold-Chain L..........

The RMAT Designation: What it means to the advanced therapy supply chain

The ever-increasing demand for healthcare advances has prompted legislators to consider means of facilitating the development of potentially life-saving new therapies. In this guest blog, Alison Wilson will review the definition of a regenerative medicine advanced therapy (RMAT) and how this designation can facilitate speed to market for these innovative therapies.  Alison is an independent regulatory affairs consultant specializing in human cell and tissue-based advanced therapies.

Content: Blog, Topic: Cell Therapy Solutions

Importance of Chain of Custody Documentation for Biologics

Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). The protection of the pharmaceutical supply chain is one of the FDA’s highest priorities, and chain of custody is one of the FDA’s primary tools in this mission. Chain of custody, when correctly executed, allows determination of “who, what, and when” with a high level of confidence. For advanced therapies—those derived or generated through biotechnology—chain of custody not only includes verification of “who, what, and when,” but also “at what temperature.”

Topic: Cell Therapy Solutions, Topic: Cold-Chain L..........

Conducting the Advanced Therapy Supply Chain Orchestra

A coordinated supply chain management plan is crucial when developing advanced therapies.

Topic: Cell Therapy Solutions, Content: Blog

Keeping It Cool: Protecting Cryopreserved Biological Samples from Degradation

As discussed on the Inside Biobanking blog, cryopreservation requires a slow cooling process to reach temperatures at or near the temperature of liquid nitrogen (−196°C). This method is standard practice in preserving biological samples. In their recent review, Woods et al. (2016) examined cryobiology applications in cryopreservation to identify new solutions to integrate into mainstream cell therapy.1

Topic: Cell Therapy Solutions, Content: Blog, Topi..........

Advanced Therapies: Reimbursement and the Impact of Hidden Supply Chain Costs

While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated.  In this blog, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.

Topic: Cell Therapy Solutions, Content: Blog

[Webinar] Cell Therapy: Achieving Success on the Road to Commercialization

As discussed by Sarah Hand on the xTalks blog, cell therapy and immunotherapy clinical trials present unique challenges to CROs and clinical sites, including patient safety considerations and complex mechanisms of action. Among the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed.

The cell therapy clinical trial supply chain can be complex, especially if the study involves multiple international sites. To understand how sponsors can reduce risk and position their product well for commercialization, Sarah Hand sat down with us to discuss the complexity associated with the cell therapy supply chain and maintaining cryogenic temperatures.

To learn more please download our webinar, Cell Therapy: Achieving Success on the Road to Commercialization, at the end of this blog.

Topic: Cell Therapy Solutions, Content: Webinar

Top Considerations to Meet FDA Requirements for Packaging Cryogenically Frozen Advanced Therapies

US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.

Topic: Cell Therapy Solutions, Content: Blog

Managing Refrigerated vs. Frozen Drug Product: What’s the Big Deal?

Here are two questions that illustrate our changing times in the pharmaceutical industry.

Content: Blog, Topic: GMP Biologics Management, To..........