| Short time frames are a major challenge in developing alternative microbiological methods for autologous cell therapy products. Ideally, results are made available in under a day. Obtaining regulatory acceptance also can be a challenge, but it is made easier if methods are included in an application (e.g., a biologics license application, BLA) rather than changing a method that is already part of an approved process. Comparing different detection platforms can be a challenge if they have different readouts, and validation packages are often extensive.
Just fill out the form to view and download the complete eBook. |
Get the eBook Now
|
