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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 ..........

Developing Immunotherapies for Cell-Based vs. Non Cell-Based Therapies

Immunotherapies harness the power of the body's own defense mechanism, the immune system, to combat disease. They were initially introduced in the form of non cell-based biologics and vaccines, such as the splurge of products known as the check-point inhibitors designed to target the PD1/PD-L1 immune pathway. An individual would be injected with a weakened form of a virus, exposing the body to the disease and prompting the immune system to produce antibodies to fight the infection from the live virus. In recent years, immunotherapies are expanding into the realm of cell and gene therapy. Cell therapy includes re-engineering the T-cell or immune cells and re-delivering these cells back the patient to treat the cancer.

Both cell-based therapies and non cell-based therapies are developed as immunotherapies and therefore they share some similar challenges in development. However, due to the nature of cell-based therapies manufacturing complexities, there are several additional challenges that must be considered. In this blog we'll take a closer look as some of the challenges that cell-based and non-cell based therapies face, and why cell-based therapies are so complex.

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

From Point A to B in the USA: Transporting Dangerous Goods

There are many things to consider when shipping dangerous goods; the type of material, how it's being transported, and the governing body all play an integral role in getting your material from Point A to Point B.

At Fisher BioServices, we are well versed in the management of dangerous goods; ranging from kit production to transportation. In this blog, we'll touch on some of the important information associated with dangerous goods, how they are transported, and the importance of personnel training.

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

Personnel Safety When Cryopreserving Biological Material

To maintain biological integrity and prevent sample degradation, biosamples can be cryopreserved. Since this requires very low temperatures, the correct preparation of these biospecimens for cryopreservation is critical; particularly when the samples are intended for use in downstream analysis such as immunological assays for detecting cell surface markers.

In our previous blog, 5 Factors to Consider When Storing Samples at Low Temperatures, we identified various procedures including proper handling, preparation, freezing, retrieval, and thawing measures that must be followed when cryopreserving samples to maintain cell viability. However, while following process to maintain sample integrity is an integral part of cryopreservation, there are also specific safety requirements that must be followed.

A recent blog by Inside Biobanking, addressed some of the hazards associated with biological material management at cryogenic temperatures. In this blog, let's explore how staff and biobank managers can ensure personnel safety by following these safety guidelines.

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

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..........

"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

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

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

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

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