9 CFR 101.6 - Cell cultures.

§ 101.6 Cell cultures.
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.
[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984]
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§ 101.6 Cell cultures.

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.

[38 FR 8426, Apr. 2, 1973, as amended at 40 FR 45419, Oct. 2, 1975; 49 FR 22624, May 31, 1984]

Title 9 published on 2015-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 101 after this date.

  • 2015-09-04; vol. 80 # 172 - Friday, September 4, 2015
    1. 80 FR 53475 - VSTA Records and Reports Specific to International Standards for Pharmacovigilance
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Proposed rule; withdrawal and reproposal.
      We will consider all comments that we receive on or before November 3, 2015.
      9 CFR Parts 101 and 116