GroundRules
9 CFR 101.6: Cell cultures.
Where this section sits in the code
- Title 9—Animals and Animal Products
- CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
- SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS
- PART 101—DEFINITIONS
When used in conjunction with or in reference to cell cultures, which may be referred to as tissue cultures, the following terms shall mean:
(a) Batches of primary cells. A pool of original cells derived from normal tissue up to and including the 10th subculture.
(b) Cell line. A pool of cells which are 11 or more subcultures from the tissue of origin.
(c) Subculture. Each flask to flask transfer or passage regardless of the number of cell replications.
(d) Master Cell Stock (MCS). The supply of cells of a specific passage level from which cells for production of biologics originate.
Collected 2026-08-27T02:24:03Z. Source file · JSON