Table 1 The CCRC-1 cell bank characterization for testing adventitious agents.

From: The hUC-MSCs cell line CCRC-1 represents a novel, safe and high-yielding HDCs for the production of human viral vaccines

Cell banks

Test Entities

Methods

Result

PCB, MCB and WCB

Bacterial and fungi

Sterility test*

Negative

Mycoplasmas

Culture method*

Negative

Indicator cell inoculation and staining*

Negative

Viruses

In vitro tests using indicator cells*

Negative

Nucleic acid testing for species-specific viruses

In vivo animal inoculation tests using the embryonated eggs, suckling mice, adult mice and rabbit and guinea pigs

Negative

Transmission Electron Microscopy test for viral particles

Negative

Tests for retroviruses*

  1. In the cell bank characterization, the MCB (master cell bank) was comprehensively tested for all testing items by all testing methods, whereas the PCB (primary cell bank) and WCB (working cell bank) were tested only by the *-labeled test methods.
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