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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..........

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.

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

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..........

Cut It Out: The Role of Gene Editing Technologies in Combating HIV

HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”

Topic: Cell Therapy Solutions, Topic: Public Healt..........

Biospecimen-Based Research and the 21st Century Cures Act

“God Willing, This Bill Will Save Lives.” So said Vice President Joe Biden, in sharing his thoughts on the potential ramifications of the passing of the 21st Century Cures Act (H.R.6), made possible by the bipartisan leadership of Republicans and Democrats in the Senate and the House on December 13th 2016.

Topic: Cell Therapy Solutions, Topic: GMP Biologic..........

A Perspective on "Expanded Access" to Experimental (Cell) Therapies

“Expanded Access,” is a regulatory pathway for physicians to gain access to experimental therapies for patients who usually do not qualify for the clinical trial. This pathway often represents one final chance against a condition that is severely debilitating and/or fatal. Often called “Compassionate Use,” the number of patients and physicians requesting access to experimental therapies has been growing steadily over the past three decades.

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

Phacilitate Cell and Gene Therapy World 2017: Streamline the path from discovery to cure


The advancements in cell and gene therapy are increasing at a rapid pace and are transforming the way we think about medicine. Whether in research or in the clinic, scientific innovators are acutely aware that every moment counts when working with these valuable therapies. To facilitate knowledge sharing and collaboration, Thermo Fisher Scientific is proud to support Phacilitate Cell & Gene Therapy World 2017 as the Platinum Sponsor.

Topic: Cell Therapy Solutions, Content: Blog

Radiation Therapy for Cancer Treatment is Undergoing a Personalized Medicine Transformation

Personalized medicine, sometimes called precision medicine, has become a major buzzword in the pharmaceutical industry. For decades, scientists and physicians have puzzled over why some treatments are very successful for one patient, while other seemingly similar patients given the same treatment fail to get better. The idea behind personalized medicine is that by characterizing genetic factors, epigenetic information, levels of RNA expression, and other individual factors, we can better target our treatments to the people most likely to respond to them.

Topic: Cell Therapy Solutions