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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.

Topic: Cell Therapy Solutions, Content: Blog

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: Biobanking and Biorepository, Topic: Cold-C..........

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

Minimizing Waste through Practical Process Improvement

Personal Protective Equipment (PPE) is necessary to ensure the safety of personnel in a biopharma environment.  However, have you ever considered the amount of waste that accumulates from the use of laboratory nitrile gloves and other single use apparel?

Topic: Biobanking and Biorepository, Topic: Labora..........

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: Biobanking and Biorepository, Topic: Labora..........

Trade Compliance: The Increasing Challenge of Transporting Material In and Outside of the US

Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!

Topic: Cold-Chain Logistics, Content: Blog

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

The Importance of Inventory Management: Do You Know Where Your Samples Are?

With the exciting advances in research and drug development, the importance of sample management has never been higher. If you have ever experienced sample management mishaps, we ask: Do you know where your samples are?

Topic: Biobanking and Biorepository, Topic: Public..........

[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.

Content: Webinar, Topic: Cell Therapy Solutions

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

Sample Integrity You Can Bank On: ISBER 2017 Annual Meeting

We are pleased to announce our participation at the International Society for Biological and Environmental Repositories (ISBER) 2017 Annual Meeting in Toronto, Ontario, Canada. This year's theme, Due North: Aligning Biobanking Practice with Evolving Evidence and Innovation. ISBER 2017 is the premier global event in the field of biorepository and specimen management and we are honored to showcase our services and products in conjunction with our parent company, Thermo Fisher Scientific at Booth #215.

Topic: Biobanking and Biorepository, 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.

Topic: Biobanking and Biorepository, Topic: Cell T..........