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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

Commercially Successful Cell Therapies : Navigating the Ultra Cold Chain Distribution Minefield

If you have a cell-based therapy in development, then you need to consider such variables as packaging, storage, inventory management, monitoring systems, distribution, and even clinical site capabilities well before you begin to prepare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA).  By sidestepping these issues until clinical trials begin, you may discover late in the game that you have inadvertently limited your product’s scalability and commercial viability, incurred unnecessary costs and complications downstream, and failed to meet FDA criteria for documentation of cold chain and chain of custody requirements.

Topic: Cold-Chain Logistics, Content: eBook

New Concepts and Tools for Advancing Stem Cell Research & Therapeutic Approach

ISSCR 2013 banner resized 600

Topic: Cold-Chain Logistics, Content: Blog