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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

Moving Biologics: Find Your Weakest Cold Chain Link

Shipping Lane Analysis resized 600You're shipping critical biological materials: do you take your chances, or do you perform a full shipper qualification and transit lane study? To answer this question, you have to decide how critical it is to maintain your product integrity.

Topic: Cold-Chain Logistics, Content: Blog

10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics, Part II

In the second part of this blog, I will discuss the remaining 5 common misconceptions I have encountered when using a dry shipper (if you haven't already read the first part of the blog, you can click here).  

Topic: Cold-Chain Logistics, Content: Poster

10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics, Part I

As the biotech world has grown, the need to ship high value cell- and tissue-based materials has increased exponentially. An invaluable tool in the quest to move material in a safe and effective manner is the dry shipper and its counterpart, the data logger. While the dry shipper is key to successfully shipping materials both internationally and domestically, misconceptions about the workings of these devices can jeopardize your success (read more about this in my other cell therapy blog - "Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Minefield").

Topic: Cold-Chain Logistics, Content: Blog

Cell Therapy Webinar: Ultra Cold Chain & Logistical Challenges
Do you have a cell based therapy in development? Have you had difficulty in meeting FDA criteria for cold chain or chain of custody requirements? Have you incurred unnecessary costs in your clinical trials due to cold chain regulations?  The importance of understanding and evaluating packaging, storage, inventory management, monitoring systems, distribution, and clinical site capabilities cannot be undervalued. If these factors are not taken into the consideration early it can lead to problems with scalability and commercial viability.
 
We will provide answers to these questions in our webinar presented by Dan O'Donnell, Associate Director of Cell Therapy Logistics on October 10, 2013 from 11:00 AM to 12:00 PM (EST).

Topic: Cold-Chain Logistics, Content: Webinar

Controlled-Rate Freezing of Cells During Ultra Cold Transit

Topic: Cold-Chain Logistics, Content: White Paper