中国工业微生物菌种保藏管理中心
中国工业微生物菌种保藏管理中心
CHINA CENTER OF INDUSTRIAL CULTURE COLLECTION
Cell Assays
Cell Assays


Cells are the key starting raw material for the production of antibodies, protein drugs, and vaccines, as well as the basis for cell therapy and gene therapy. The quality of cells, the stability of their characteristics, and the degree of species difference significantly influence the entire process of research and development, production, and clinical application of biologics. Pharmacopoeia of the People's Republic of China (ChP) has made clear provisions for the testing and quality control of biologics in the main chapters for biologics production management and quality control, requiring comprehensive testing of cell banks. Regulations, such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), also provide guidelines for cell quality testing, which specify that adequate testing for cell bank allows its use in production. Therefore, the cell assay report is an essential material in investigational new drug (IND) applications for biologics research and development and Non-disclosure Agreement (NDA), as well as the mandatory item to be audited for audit departments such as CDE and FDA.

China Center of Industrial Culture Collection (CICC) provides quality testing services for human and mammalian cell seeds, master cell Banks (MCB), working cell banks (WCB), end-of-production cells (EOPC), and unprocessed bulk (UPB). To meet the personalized needs of domestic and foreign customers for product declaration, technical service solutions can be customized in terms of testing parameters, testing methods, data analysis, etc., taking into account different cell types of biological products (e.g., immune cells, stem cells).

Items number Items Content Workdays

CICC-ISOEN

Cell Identification Test

Identification of cell isozyme

30

CICC-STR

Short Tandem Repeats (STR) Analysis

20

CICC-KARYO

Chromosome karyotype analysis

30

CICC-STERI(DI)

Bacterial and Fungal Sterility Test

Sterility test - Direct inoculation method

35

CICC-STERIMF

Sterility test - Membrane filtration method

35

CICC-MYCOB

Mycobacterium Test

Mycobacterium test - Direct inoculation method

70

CICC-MYCOP(DC)

Mycoplasma Test

Mycoplasma test-Culture method

45

CICC-MYCOPCELLCUL

Mycoplasma test- Indicator cell culture method ( DNA staining method)

30

CICC-MORHEMA

Cell Endogenous and Exogenous Viral Factors Test

Cell morphological observation and hemadsorption test

45

CICC-INCUL

In vitro inoculation and culture of different indicator cells

45

CICC-SUMICE

In vivo animal inoculation -Inoculation in suckling rats

60

CICC-ADUMICE

In vivo animal inoculation- Inoculation in adult rats

60

CICC-GUINEA

In vivo animal inoculation - Inoculation in guinea pigs

60

CICC-RABB

In vivo animal inoculation - Inoculation in rabbits

60

CICC-CHICK

In vivo animal inoculation - Inoculation in chick embryos

60

CICC-RETRANS

Retrovirus detection - Activity determination of reverse transcriptase

30

CICC-RETROTEM

Retrovirus detection - Transmission electron microscopy method

40

CICC-INFEC

Retrovirus detection - Infectious test

40

CICC-SPEC

Species-specific exogenous viral factor testing (murine) PCR method 

30

CICC-HUVI

Species-specific exogenous viral factor detection(human) PCR method 

30

CICC-BOVI

Bovine-derived virus detection PCR method

30

CICC-PORC

Swine-derived virus detection PCR method

30

CICC-OTHU

Other specific virus detection PCR methods (human)

30

CICC-OTMI

Other specific virus detection PCR methods (murine)

30

CICC-TUMO

Tumorigenicity Test

Tumorigenicity Test

130

CICC-ONOC

Oncogenicity Test

Oncogenicity Test

130


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