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Optimizing Advanced Therapy Supply Chain Design to Ensure Commercial Success

The advanced therapy supply chain is complex and made up of multiple moving parts. With milestone achievements such as the recent FDA approval of Novartis' CAR-T cell therapy Kymriah™ it's essential that we address the challenges of delivering these ground breaking therapies to patients on a global scale.

Topic: Cell Therapy Solutions, Topic: Cold-Chain L..........

Use of Mobile Technology to Enhance Biospecimen Quality and Biobank Efficiency

Population-based biobanking is an essential aspect of biomedical research. When biobank samples are collected outside of clinical or research facilities, chances for variation in sample collection, handling, and shipping increase. Any lack of standardization before, during, or after collections can generate unwanted pre-analytical variability that hurts future use of biospecimens.

Topic: Biobanking and Biorepository, Topic: Public..........

[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.

Topic: Cell Therapy Solutions, Content: Webinar

[Webinar] The Seven Keys to Safeguarding Your Cryopreserved Cells

Safeguarding your samples throughout the entire cryopreservation process can be tricky and even unproductive, thanks to protocols that unknowingly undermine your results. Understanding the seven keys to protect your cryopreserved cells – from selecting the right storage temperatures and proper cooling methods to avoiding common safety hazards when using liquid nitrogen – can equip any lab with the knowledge necessary to ensure sample safety and optimal cryopreservation results.

Thermo Fisher Scientific's on-demand webinar, The Seven Keys to Safeguarding Your Cryopreserved Cells, explores the many variables involved in planning for cryopreservation in your cell culture process. Let's explore these steps and unlock the critical information to ensure high cell viability. 

Topic: Laboratory Processing, Content: Webinar, To..........

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..........

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