|
|
|
|
| Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne. |
|
|
|
|
By Erin Harris, Editor-In-Chief, Cell & Gene | The industry recently celebrated Rare Disease Day, which took place on February 29 — the rarest day of the year. Rare Disease Day is a global initiative to raise awareness and generate support for everyone who is on a rare medical journey. |
|
|
|
|
By Life Science Connect Editorial Staff | More than 300 million people worldwide live with a rare disease, and regulatory requirements don't change for demonstrating their safety and efficacy. The FDA has acknowledged the need for additional flexibility in applying these standards to rare diseases, as well as a willingness to rely on less certainty when appropriate. |
|
|
|
|
| Response To FDA Black Box Warning | White Paper | Theragent | The FDA recently launched an investigation into the risk of T-cell malignancies. Review key areas concerning this announcement in the interest of the research community. |
|
|
|
|
| Prioritize Safety And Mitigate Risk In HPAPI Manufacturing | White Paper | By Dr. Karel Vervisch, Ajinomoto Bio-Pharma Services | As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality. |
|
|
|
|
|
|
| Connect With Cell & Gene: |
|
|
|
