[Webinar] Cell Therapy: Achieving Success on the Road to Commercialization
As discussed by Sarah Hand on the xTalks blog, cell therapy and immunotherapy clinical trials present unique challenges to CROs and clinical sites, including patient safety considerations and complex mechanisms of action. Among the most important components to a successful cell therapy clinical trial is the necessity of controlling the environmental conditions to which the biological product is exposed.
The cell therapy clinical trial supply chain can be complex, especially if the study involves multiple international sites. To understand how sponsors can reduce risk and position their product well for commercialization, Sarah Hand sat down with us to discuss the complexity associated with the cell therapy supply chain and maintaining cryogenic temperatures.
To learn more please download our webinar, Cell Therapy: Achieving Success on the Road to Commercialization, at the end of this blog.
Content: Webinar, Topic: Cell Therapy Solutions
Top Considerations to Meet FDA Requirements for Packaging Cryogenically Frozen Advanced Therapies
US Food and Drug Administration (FDA) requirements specify that packaging and distribution systems must protect the agent from contamination and damage. In distributing cryogenically frozen advanced therapies, this includes protection from temperature shock.
Topic: Cell Therapy Solutions, Content: Blog
Sample Integrity You Can Bank On: ISBER 2017 Annual Meeting
We are pleased to announce our participation at the International Society for Biological and Environmental Repositories (ISBER) 2017 Annual Meeting in Toronto, Ontario, Canada. This year's theme, Due North: Aligning Biobanking Practice with Evolving Evidence and Innovation. ISBER 2017 is the premier global event in the field of biorepository and specimen management and we are honored to showcase our services and products in conjunction with our parent company, Thermo Fisher Scientific at Booth #215.
Topic: Biobanking and Biorepository, Content: Blog
Managing Refrigerated vs. Frozen Drug Product: What’s the Big Deal?
Here are two questions that illustrate our changing times in the pharmaceutical industry.
Topic: Biobanking and Biorepository, Topic: Cell T..........
ISCT 2017: Optimizing your Advanced Therapy Supply Chain
Ensuring that your therapy is delivered to the intended patient at the correct time and temperature are all key components for commercialization. To accomplish this, an optimized supply chain is imperative. Fisher BioServices understands these important factors and offers our global infrastructure and services to support the commercialization of advanced therapies.
Topic: Cell Therapy Solutions, Content: Blog
INSIGHTS Europe: Key Takeaways in Support of Advanced Therapies
Advanced therapies are rapidly becoming a viable therapeutic option. Thus, to ensure a patient receives an effective therapy, the supply chain will need to evolve from a clinical trial logistics paradigm to an inter-related coordinated supply chain.
Topic: Cold-Chain Logistics, Topic: Cell Therapy S..........
Some Steps Toward Fit-For-Purpose, Future-Proof Specimens
We spill a good bit of virtual ink in our blogs and eBooks discussing biospecimen integrity, but the emerging term that is being used more and more often, is “fit–for-purpose.” Identifying a sample as fit-for-purpose implies molecular integrity, but goes beyond this to encompass all the variables that make a biological sample useful for research. Sample integrity focuses on the quality of individual samples, while the term fit-for-purpose can be interpreted as addressing entire collections.
Topic: Biobanking and Biorepository, Topic: Labora..........
Storing Biologics at Non-Traditional Temperatures
Maintaining the appropriate storage temperature of biological material is critical for downstream use. However, due to the complexity of this material and its sensitivity to temperature we are seeing an increase in non-traditional storage temperature requests. In this blog we’ll explore some of the reasons why this is occurring and the associated challenges.
Topic: Biobanking and Biorepository, Topic: GMP Bi..........
INSIGHTS Europe: Addressing the Challenges of Supply Chain Management for Clinical Trials
Clinical supply professionals face many challenges in today’s world of clinical supply chain management. Tracking systems, temperature monitoring devices, courier capabilities, and regulations are all changing to accommodate both the increasing numbers of biotherapeutic products moving through the supply chain and the increasingly stringent criteria for temperature compliance. In partnership with Fisher Clinical Services, we invite you to INSIGHTS Europe; a complimentary forum with guest speakers and roundtable discussions on key issues impacting clinical supply management today.
Topic: Cold-Chain Logistics, Content: Blog
Cut It Out: The Role of Gene Editing Technologies in Combating HIV
HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”
Topic: Cell Therapy Solutions, Topic: Public Healt..........
The Evolution of Public Health Research—A Summary of the Blog Series
Over the past year, we presented a series of blog posts on The Evolution of Public Health Research, our salute to a profession and area of study that has not only saved many, many millions of lives, but also dramatically improved the length and quality of life as well.
Content: eBook, Topic: Public Health Research, The..........
"Validation" or "Qualification" – What’s the difference?
I face this question on a regular basis from my clients, both internal and external. So what is the difference between qualification and validation?
Topic: Qualification / Validation, Topic: GMP Biol..........