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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

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..........

INSIGHTS Europe: Addressing the Challenges of Supply Chain Management for Clinical Trials

Clinical supply professionals face many challenges in today’s world of clinical supply chain management. Tracking systems, temperature monitoring devices, courier capabilities, and regulations are all changing to accommodate both the increasing numbers of biotherapeutic products moving through the supply chain and the increasingly stringent criteria for temperature compliance. In partnership with Fisher Clinical Services, we invite you to INSIGHTS Europe; a complimentary forum with guest speakers and roundtable discussions on key issues impacting clinical supply management today.

Topic: Cold-Chain Logistics, Content: Blog

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..........

Supporting our Troops - Transporting the AFMES DNA Repository to Dover Air Force Base

In observance of the upcoming Veterans Day holiday on November 11, we'd like to share a case study on how the Fisher BioServices team actively supports our troops and share our appreciation for all that they do. Together with our parent company, Thermo Fisher Scientific, we work with veterans to make the world a healthier place.

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

Expansion Cohort Clinical Trials and Your Cryogenic Supply Chain

One advantage to the traditional phase 1, 2, and 3 format of clinical trials is that it allows reasonable forecasting with regard to the clinical supply chain. This phase 1-2-3 format is rapidly changing, however, especially with regard to biological therapies, as more and more clinical trials include expansion cohorts. If you are planning clinical trials for a cell-based therapy that must be maintained in liquid nitrogen, and may potentially take the expansion cohort route, you should consider the impact on your distribution capabilities as soon as possible.

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

The Importance of Early Planning for Clinical Supplies: Part II

In Part I of this blog series, I identified some of the challenges in supporting clinical trials and a few reasons why early planning for clinical supplies is very important. In Part II, let’s look at three areas of clinical supply support that can greatly benefit from having the support team involved from the start and given ample time to design and contribute to the protocol:

Topic: Cold-Chain Logistics, Topic: Clinical Trial..........

The Importance of Early Planning for Clinical Supplies: Part I

Beating other investors to an offer or getting ample time to support a clinical trial can yield big benefits and returns. The advantages from the financial perspective can be fairly evident but the gains from having plenty of time to plan, design and implement support functions for clinical supplies may not be so obvious. In this two part blog series, I will discuss the challenge of supporting clinical trials and the importance of early planning for clinical supplies.

Topic: Cold-Chain Logistics, Topic: Clinical Trial..........

Large-Scale Freezing of Biologics: Advantages and Challenges

Biopharmaceutical companies often produce millions of units of bulk biological materials that are then distributed for clinical use. This represents a significant supply chain challenge, as these materials need to be maintained within very specific environmental parameters. Temperature, humidity, and stress during material handling must be tightly controlled to prevent degradation of quality. Large-scale freezing of biologics provides a safe and effective method of storing biological materials, but this approach comes with unique challenges.

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

The Growing Public Health Concern Surrounding Zika

Over the past several weeks, the Zika virus has morphed from an obscure disease into an international public health emergency, gaining global attention. This has left the public health research community with many questions; Where did the disease originate? How is it transmitted? How do we work together to develop and distribute a vaccine?

In this blog we'll explore the existing information surrounding the Zika virus and some of the challenges associated with vaccine development.

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

EU Commission Guidelines on Good Distribution Practice of IMP

Over the past few years there has been a notable increase in the number of temperature-controlled clinical supplies being transported all over the world. This increase can be attributed to the fact that a larger number of clinical trial drugs being tested today are of a biological nature. However, as discussed on the Fisher Clinical Services INSIGHTS blog, until recently little thought was given to ambient drug (generally set to be stored within 15°C – 25°C) being transported through a temperature controlled method as well.

Topic: Cold-Chain Logistics, Topic: GMP Biologics ..........

Accidental Freezing of Vaccines

When discussing the impact of temperature on vaccines, heat is the better-known hazard. However, while the vaccine cold chain is a way to protect vaccines from inactivation associated with high temperatures, exposure to low temperatures can also result in potency losses. In a 2007 study, researchers found that vaccines were exposed to freezing temperatures in 14 to 35 percent of refrigerators or transport shipments. Thus, accidental freezing of vaccines poses a significant and growing threat to national immunization programs. And in locations where the equipment is not qualified or the process is not validated, the impact of environmental temperatures on the vaccines could be significant.

Topic: Cold-Chain Logistics, Topic: Qualification ..........