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Transporting Critical Bio-Material: How do you safely move an irreplaceable biospecimen collection?

Are you faced with the task of relocating a biospecimen collection? Moving a substantial inventory of samples is a logistical challenge, and requires managing temperature, equipment, regulatory, and personnel safety issues. The choice of vehicle used for transport may be low on the list, but the right truck can be critical to success.

Topic: Cold-Chain Logistics, Content: Poster, Topi..........

Population Study Identifies Immunosuppression Associated with Measles

As we discussed in our previous post, vaccines are more prevalent now than ever before and maintaining the vaccines' integrity is of utmost importance. Additionally, it is also important to discuss how the lack of vaccination can have an irreversible impact on the immune system. Previously we identified the importance of safeguards surrounding cold chain in handling high-value material, such as vaccines. For this post, let's explore how data gathered from population studies is being used to understand the implications of disease and vaccinations on the immune system.  

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

"Vaccine” and “Cold Chain” are Inseparable

Vaccines are back in the news, whether an Ebola vaccine or advocacy for vaccine use in general. This news focus is much needed, particularly to highlight the importance of safeguards surrounding cold chain in handling vaccines. As the Head of Metrology at Fisher BioServices, the one constant, central, critical, working variable in my life is maintaining materials at the correct temperature, from point A to point B, and effective vaccines require effective temperature control. 

Topic: Cold-Chain Logistics, Content: Blog

Challenges Associated with Controlled Room Temperature Logistics

The shipping and data monitoring of cold chain logistics is a hot topic within our industry. When your products leave your care, the data you receive helps to ensure your peace of mind by validating the products’ integrity throughout the chain of custody process. As our world becomes more focused on data to support efficiency it is becoming increasingly important to monitor if product integrity has been impacted by environmental problems. But at what cost? 

In the past, we've discussed some of the concerns, considerations, and best practices associated with ultra cold chain logistics of high value biologics and biosamples. However, there are many challenges associated with controlled room temperature (CRT) logistics as well. Recently, I had the opportunity to discuss these challenges with some of our internal experts who deal with these types of shipments frequently, and have summarized them into six basic points below!

Topic: Cold-Chain Logistics, Content: Blog

Top 10 Concerns and Considerations in Cold Chain Logistics

There are many things to consider when shipping your high-value, temperature sensitive products using a cold chain logistics process.  These range from complying with regulatory standards set by the International Air Transport Association (IATA), Department of Transportation (DOT), Transportation Security Administration (TSA), and U.S. Customs and Border Protection (CBP), to including the correct domestic or international documentation to accompany your shipment on its journey.  Our list of top 10 concerns and considerations in cold chain logistics will help increase your knowledge of the process, understand how to avoid the common pitfalls often made, and implement the necessary parameters to ensure your product arrives safely and intact to its final destination.

Topic: Cold-Chain Logistics, Content: Blog

Canada’s Premier Cold Chain Logistics Event

Cold_Chain_GDP_and_Temperature_Management_Logistics_Summit_2015

The 13th Annual Cold Chain GDP & Temperature Management Summit, Canada's premier cold chain logistics event, is being held this week in Montreal. This year's agenda includes an expanded program focused on clinical supply, biologics, supply chain integrity, and small pharma and biotech supply chains. Speakers from across the life sciences industry are scheduled to present diverse viewpoints on topics ranging from biologics distribution and requirements to temperature mapping.  Attendees will have the opportunity to network with companies operating in pharmaceuticals, health technologies, biotechnology, and contract manufacturing/research, as well as visit warehouse and distribution facilities in one of Canada’s biggest logistics hubs.

Topic: Cold-Chain Logistics, Content: Blog

Best Practices for Managing Cold Chain Shipments

If you have a cell-based therapy in development, there are several variables and best practices to consider before you begin to prepare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).  These variables may include packaging, storage, inventory management, monitoring systems, distribution, and even clinical site capabilities.  Fisher Clinical Services' blog, entitled Insights Online, recently featured a two part blog series that identified the Best Practices for Managing Cold Chain Shipments.  In total there were 8 comprehensive steps that advised readers on ways to ensure their products' integrity throughout the cold chain logistics shipping process.

Our end-to-end cold chain solution allows our customers to ship their products at a wide range of temperatures, ranging from ambient to cryogenic.  Before scheduling your next shipment, take a moment to answer the questions below.  By understanding how these questions apply to your products, we can work together to ensure the best practices for managing cold chain shipments are followed. 

Topic: Cold-Chain Logistics, Content: Blog

Developing Ebola Vaccine and Securing Your Cold Chain Logistics Plan

Recent reports issued by the Centers for Disease Control and Prevention (CDC) show that efforts to contain the Ebola outbreak are yielding results. And even as we applaud the news, and also understand the need to continue the current efforts at an intense level, our collective attention is turning to the next step: developing a vaccine to prevent another outbreak.

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

Latest Ultra Cold Chain Global Challenges to be Discussed at Key Events

We at Fisher BioServices are excited to share our recent and upcoming participation at three industry conferences, with three opportunities to provide new case studies and insights. Dan O'Donnell, our Director of Cell Therapy Logistics, who is widely known for his expertise in ultra cold chain distribution and regulatory compliance in the transport of biologics and cell-based therapeutics, will speak at two of these events. Both occur in September, in Boston: Mr. O'Donnell recently spoke at the Stem Cell and Regenerative Medicine Conference on September 15th and 16th (speaking on the 15th), and for those who missed this event, Mr. O'Donnell will present again at the 12th Annual Cold Chain GDP & Temperature Management Logistics Global Forum from September 29th through October 3rd (speaking on the 30th). He will also be exhibiting at the Stem Cell Meeting on the Mesa in La Jolla, CA, on October 7th through 9th. Dan also recently published a video blog that you can find in this previous post

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

Biobank Relocation: Should the Freezer Units be ON or OFF?

Are you relocating an entire freezer full of research specimens? The ideal scenario is to leave the specimens in the cold storage unit and to transport the entire unit—which means keeping it in operation while it is in transit. However, refrigerators and freezers were never designed to operate while in motion, and keeping them running while bumping along a highway can damage the compressors, void the warranty, cause unit failure, and—why risk it?—allow your samples to thaw.

However, there is a way to transport freezers with the specimens inside, maintain correct temperature, and still protect the compressors: turn the units off and use controlled injection of liquid nitrogen (LN2) to maintain correct temperature.

Topic: Cold-Chain Logistics, Content: Blog

Top Clinical Trial Supply Chain Challenges...(and How to Overcome Them)

 

In her most recent post on the Fisher Clinical Services BlogPam Osborne concludes her series on managing the clinical trial supply chain with a 10-step summary for overcoming the biggest challenges. Even if you're conducting "non-clinical research" that doesn't have a patient as the endpoint, many of the steps she outlines should be followed to ensure your valuable product is kept safe and secure.

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

Fisher BioServices Experts to Share Latest Cell Therapy Commercial Development and Cold Chain Challenges at the 2014 Cell & Gene Therapy Forum


cell therapy circle resized 600As newly developed biopharmaceuticals move through clinical trials toward commercialization, the number of variables surrounding the handling and distribution of these high value cell- and tissue-based materials have increased exponentially. The packaging, storage, inventory management, monitoring systems, and distribution must all be carefully considered in meeting FDA and patient safety requirements.

Topic: Cold-Chain Logistics, Content: Blog