A discussion to help establish release specifications for master cell banks of parental host cells
This article proposes a platform approach for testing one of the system’s most critical starting materials, master cell banks (MCBs) of human origin used for the generation of adeno-associated virus (AAV) or lentivirus (LV) for use in GT; and of insect origin used for the generation of AAV for use in GT. Consensus on test attributes and release requirements across the industry is aimed to streamline control of this material. The purpose of this article is to identify, share, and enhance a framework for master cell bank (MCB) testing and release. It is intended to increase the speed of learning and ultimately influence and/or aid regulatory agencies in developing guidance or policies around GT development and manufacturing.
BioPhorum Cell & Gene Therapy have provided a confidential online survey for readers to give open and honest feedback. Please comment on the questions in this article and raise any further questions that can be discussed to develop this platform approach.
|Discussion to help establish release specifications for MCB of parental host cells July 2021.pdf|
|Gene therapy cell release specifications survey July 2021.pdf|
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