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Determining Optimum Maintenance Temperature for Advanced Therapies, Part 2

As discussed in my previous blog, there are many factors that need to be considered when selecting an effective maintenance temperature. Those factors include volume, handling processes, storage, and equipment. In part two of this blog series, I will focus on the impact that some of these variables can have on determining an optimum maintenance temperature for advanced therapies.

Topic: Cell Therapy Solutions, Topic: Biobanking a..........

Determining Optimum Maintenance Temperature for Advanced Therapies, Part 1

As referenced in a previous blog post, understanding the proper method of safely cryopreserving your material is essential, but of equal importance is determining the optimum maintenance temperature. There are many factors that need to be considered when selecting an effective maintenance temperature. Those factors include volume, handling processes, storage and handling equipment and the impact of multiple short duration exposures. In this two part blog series, we’ll discuss four areas that need to be understood to determine the optimum maintenance temperature for advanced therapy material.

Topic: Cell Therapy Solutions, Content: Blog, Topi..........

Keeping It Cool: Protecting Cryopreserved Biological Samples from Degradation

As discussed on the Inside Biobanking blog, cryopreservation requires a slow cooling process to reach temperatures at or near the temperature of liquid nitrogen (−196°C). This method is standard practice in preserving biological samples. In their recent review, Woods et al. (2016) examined cryobiology applications in cryopreservation to identify new solutions to integrate into mainstream cell therapy.1

Topic: Cell Therapy Solutions, Content: Blog, Topi..........

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..........

Cell Therapy Clinical Trials: Navigating the operational shift from Phase 1 to Phase 2

When navigating through the various phases of a cell therapy clinical trial, it's important that each phase "sets the stage" for those which follow. All activities that take place in Phase 1 will ultimately impact Phase 2, and so on through to commercialization. This blog will focus on the operational shift from Phase 1 to Phase 2 and the associated challenges with doing so.

Topic: Cell Therapy Solutions, Topic: Kit Producti..........

Amazing Samples: Progenitor Cells

Of all the advances medicine has been making in recent years, regenerative medicine is perhaps the most intriguing. One of the most important cells involved in regenerative medicine is the progenitor cell. These cells are able to differentiate into more functional cells, making our understanding of them and their mechanisms crucial to regenerative medicine and cell therapies.

Last time in our Amazing Samples blog series my colleague, Jaydeb Mukherjee, discussed the research potential of saliva and phlegm. This time, let’s discuss more on how progenitor cells are an Amazing Sample.

Topic: Cell Therapy Solutions, Topic: Amazing Samp..........

Clinical Trial Identifies New CAR T-Cell Therapy to Fight Leukemia

Two of our previous blogs, Viral Cell Therapies Fighting Cancer and Researchers Learn How to Turn Cancer Cells into Macrophages, discussed the challenges associated with Acute Lymphoblastic Leukemia (ALL) and some of the medical breakthroughs being used to fight this difficult disease. A recent article in Blood Journal explains how recurrent ALL is very difficult to treat, but suggests there is real hope for finding a lasting curative therapy for refractory patients. Let's explore the studies findings and uncover additional information on the research into potential ALL cell therapy treatment modalities.

Topic: Clinical Trial Sample Management, Topic: Ce..........

Cell Therapy Logistics: Beyond the Basics

My previous eBook, Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Distribution Minefield, and several of my blogs, have discussed the basics of building a successful logistics strategy for the management of cell-based material. If you read these, then you are aware of the better-known and important factors to consider, such as:

Content: eBook, Topic: Cell Therapy Solutions

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

Qualification and Validation Webinar: How to Manage Cold Chain Qualification When Handling High Value Biologics

As cold chain and ultra cold chain logistics have become an increasingly important element in the shipping of high volume medical, biologics, and other critical biological materials. The need to create an effective strategy to ensure packaging integrity has become a topic of great interest. 

Topic: Qualification / Validation, Content: Webina..........

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

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