2015 has been a year filled with new discoveries in the health and medical R&D space. Through our blog, we have shared great stories of our customers' work and discussed a wide-breadth of topics, focusing on cell therapies, biological material, and public health research.
In case you missed some of the content we published over the last year, we've created a Fisher BioServices Top Five list of our most popular blogs of 2015. Take a look!
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. This blog discusses how progenitor cells are an Amazing Sample.
Standardize Your Sample and Temperature Management with CryoCradle™
While freezers and shippers have both been improved over time, the standard procedure for keeping specimen vials in ultra-low range between freezer and shipper has generally stayed the same: placing the vials on a simple dry ice bed. After observing how much cryoboxes could warm during out-of-freezer handling, we developed the CryoCradle™ as a countermeasure.
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 focuses on the operational shift from Phase 1 to Phase 2 and the associated challenges with doing so.
Long-term Biobanking: How long can you hold samples?
Biobanks are an essential component of medical research. However, in some cases researchers may retrieve samples from the biorepository only to find that the materials stored are no longer viable for testing. In order to prevent a loss of integrity among samples, all parties involved in the collection and storage of biospecimens must follow certain practices. For best results, these procedures should be based on up-to-date, relevant research studies that demonstrate the most effective methods for storing specimens, as well as the maximum length of time they can be stored safely. So what does our current research say?
Why GMP? An explanation of Good Manufacturing Practice
GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211. In this blog we discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.
We hope you enjoyed this recap and want to thank you for being a part of our blog community. Stay tuned for fresh, new content in 2016!