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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..........

Implementing Pre-qualified Shippers into Ambient and Controlled Room Temperature Operations

Whether you are working with cell therapies, biologics, drug product, or biospecimens, temperature is an omnipresent concern that requires your attention. From a logistics standpoint, maintaining appropriate temperature conditions is of utmost importance to ensure your material arrives at its final destination with its integrity intact. Therefore, it is no surprise that within our industry the definition of cold chain is expanding beyond cold temperatures to include both ambient and controlled room temperature (CRT) shipments.

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

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.

The best mode of transportation for moving your irreplaceable sample collection from Point A to Point B may not be one you are familiar with. This InfoPoster explores the pros and cons associated with the well-known (standard) option vs. specialized transport services and associated ancillary equipment. Getting familiar with all of your options will lead to a better decision.

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

Vaccine_Vial

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 ..........