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:
- Selecting the right dry shipper
- Qualifying that shipper to the particular payload and shipping configuration
- Choosing an appropriate data logger
- Creating a chain of custody
- Evaluating a transit carrier
- Anticipating potential problems inherent in shipping at cryogenic temperatures
This eBook goes beyond the basics and acquaints you with some of the lesser known considerations. Although they may be hidden in the background, these factors can play a major role in the success or failure of a clinical trial and the long term efficacy of a cell-based commercial product. They are:
- Package and shipping qualification
- Equipment validation
- Process qualification
- Documenting the chain of custody
I am focusing this eBook on the unique logistical challenges of autologous cell-based therapies, that is, therapies that use a patient’s own cells for the manufacture of a treatment that is then administered only to that patient. The other type of cell-based therapy is referred to as“allogeneic” and is derived from an unrelated donor or donors, and administered to the relevant population of patients. All of the considerations I mentioned above apply to allogeneic as well as autologous therapies.
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
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 ..........
"24 Hours of Stem Cells" Virtual Event for Cell Therapy Researchers
We at Fisher BioServices are proud to announce our participation in Life Technologies' upcoming virtual event, the 2nd annual 24 Hours of Stem Cells. From 6 pm EST on November 5th through 8 pm EST on November 6th (11 pm Nov. 5th to 1 am Nov. 7th GMT), you can connect with other researchers, visit virtual booths with digital resources, and hear discussions on various topics from speakers around the world! And as a virtual event, you can connect on your own terms, whenever and from wherever you want.
Topic: Cell Therapy Solutions, Content: Blog
Amazing Samples: Antibodies
Antibodies are one of the most basic yet precise elements of the immune system: each antibody is associated with a specific antigen that fits to it like a key to a lock, and by binding to the antigen it serves to paint a target on the associated cell for other, more aggressive elements of the immune system to attack. Although antibodies were discovered more than a century ago – German immunologist Paul Ehrlich first coined the term Antikörper in an article he published in 1891—their use as therapeutic agents was limited by our lack of immunological methods.
Enter hybridoma technology. By fusing B-cells that produce the desired antibody with myeloma cells, it became possible to create a colony of hybridomas, all producing antibodies with identical antigen-specificity. Since the technology to humanize these monoclonal antibodies (mAbs) was developed in the late 1980’s, followed by chimeric and ‘fully’ human mAbs, many mAb-based therapies have been developed for a broad range of conditions, from viral to cancerous to inflammatory. However, these antibodies are very fragile and sensitive to temperature, and have to be stored and transported in ultra-low temperatures and sometimes down to liquid nitrogen, so we at Fisher BioServices have proudly had many opportunities to assist in the development and distribution of these biologics-based therapies. Last time, we discussed how cancer cells can be turned against themselves – this time, let’s showcase some of the different ways that monoclonal antibodies are truly Amazing Samples.
Topic: GMP Biologics Management, Topic: Amazing Sa..........