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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.

Content: Blog, Topic: Cell Therapy Solutions

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

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!

Content: Blog, Topic: Cold-Chain Logistics

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, Content: Blog..........

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.

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

ISCT 2017: Optimizing your Advanced Therapy Supply Chain

Ensuring that your therapy is delivered to the intended patient at the correct time and temperature are all key components for commercialization. To accomplish this, an optimized supply chain is imperative. Fisher BioServices understands these important factors and offers our global infrastructure and services to support the commercialization of advanced therapies.

Content: Blog, Topic: Cell Therapy Solutions

INSIGHTS Europe: Key Takeaways in Support of Advanced Therapies

Advanced therapies are rapidly becoming a viable therapeutic option. Thus, to ensure a patient receives an effective therapy, the supply chain will need to evolve from a clinical trial logistics paradigm to an inter-related coordinated supply chain.

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