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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..........

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.

Topic: Cell Therapy Solutions, Content: Blog

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: Cold-Chain Logistics, Topic: Cell Therapy S..........

Some Steps Toward Fit-For-Purpose, Future-Proof Specimens

We spill a good bit of virtual ink in our blogs and eBooks discussing biospecimen integrity, but the emerging term that is being used more and more often, is “fit–for-purpose.” Identifying a sample as fit-for-purpose implies molecular integrity, but goes beyond this to encompass all the variables that make a biological sample useful for research. Sample integrity focuses on the quality of individual samples, while the term fit-for-purpose can be interpreted as addressing entire collections.

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

Storing Biologics at Non-Traditional Temperatures

Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this blog we’ll explore some of the reasons why this is occurring and the associated challenges.

Topic: Biobanking and Biorepository, Topic: GMP Bi..........