Mammalian Cell Bank Characterization
(Form YY)
Please print and complete this form and forward/fax to MDS. We will contact you for a detailed quotation.
Institution:
Email:
Billing Address:
Submitted by:
Shipping Address:
Zip:
Fax:
Investigator:
Date Submitted
/
/
PO #:
State:
Tel:
Type of Cells:
Primary
City:
Ext:
Human
Animal
Immortal
Transformed/Transgenic
Master Cell Bank (MCB)
Working Cell Bank (WCB)
End of Product Cell Bank EPCB)
ID as it appears on the submitted sample:
Culture medium to be used:
Culture Reagent
Type
Manufacturer
Cat. #
Final Concentration in
Culture Medium
Medium
Serum
Additional
Supplements
Environmental conditions:
Temperature:
Humidity:
%CO2:
Adherent
Non-adherent
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Identity Testing
Karyotyping
Genetic profiling (STR)
Total viable cells/vial
Cell viability (post-bank thaw)
Isoenzyme electrophoresis
Glucose-6-phosphate dehydrogenase
(G6PD)
Lactate dehydrogenase (LD)
Malate dehydrogenase (MD)
Nucleoside phosphorylase (NP)
Form YY
MCB
WCB
EPCB
MCB
WCB
EPCB
MCB
WCB
EPCB
MCB
WCB
EPCB
MCB
WCB
EPCB
Aspartate aminotransferase (AST)
Peptidase B (PepB)
G-Protein coupled receptors (GPCR)
cAMP phosphodiesterase (cAMP)
Protein kinase (PK)
Form YY
Page 2
Purity
In vitro adventitious virus testing
MCB
WCB
EPCB
In vivo adventitious virus testing
MCB
WCB
EPCB
In vitro Assay, Detection of porcine Viral Contaminants using PPK cells According to 9CFR
MCB
WCB
EPCB
F-PERT Assay
MCB
WCB
EPCB
Retrovirus 293 Co-cult (5 Passages, FPERT End-point)
MCB
WCB
EPCB
PCR testing for human viruses and Mycoplasma for
EBV (HHV 4, Human Herpes Virus, Epstein-Barr)
Hepatitis A Virus (HAV)
Hepatitis B Virus (HBC)
Hepatitis C Virus (HCV)
Human Cytomegalovirus (CMV)
Human Herpes Virus 1 (HHV1)
Human Herpes Virus 6 (HHV6)
Human Herpes Virus 7 (HHV7)
Human Herpes Virus 8 (HHV8)
Human Immunodeficiency Virus-1 (HIV1) DNA
Human Immunodeficiency Virus-1 (HIV1) RNA
Human Immunodeficiency Virus-2 (HIV2) DNA
Human Immunodeficiency Virus-2 (HIV2) RNA
MCB
WCB
EPCB
Human Papilloma virus -16 (HPV-16)
Human Papilloma virus -18 (HPV-18)
Human Rotavirus (HRV)
Human T-Cell Leukemia Virus Type 1 (HTLV1) DNA
Human T-Cell Leukemia Virus Type 1 (HTLV1) RNA
Human T-Cell Leukemia Virus Type 2 (HTLV2) DNA
Human T-Cell Leukemia Virus Type 2 (HTLV2) RNA
Influenza
Measles
Norwalk Virus (NW)
Parvovirus B19 (Parvo-B19)
Rubella
Enterovirus (polio)
PCR testing for bovine viruses
Bovine viral diarrhea virus (BVDV)
Bovine parvovirus (BPV)
Bovine adenovirus (BAV)
Bluetongue virus (BTV)
Bovine respiratory syncytial virus (BRSV)
MCB
WCB
EPCB
Reovirus (RV)
Rabies virus
Bovine Herpes Virus I (BHV I)
Bovine Herpes Virus IV (BHV IV)
PCR testing for porcine viruses
Simian viruses (SV40 and SV-5)
African swine fever virus (ASFV)
Classical swine fever virus (CSFV)
Foot and mouth disease virus (FMDV)
Japanese encephalitis virus
MCB
WCB
EPCB
Swine vesicular disease (SVD)
Vesicular exanthema (VE)
Vesicular stomatitis
Porcine Circovirus-1 and 2 (B/PCV1)
Swine hepatitis E Virus (HEV)
Testing for animal viruses according to 9 CFR 113.46, 113.47 and 113.53, using cell culture
monolayers
MCB
WCB
EPCB
Testing serum alone for bovine diarrhea virus (BVDV1) and bovine rotavirus (BRV)
Testing trypsin alone for Porcine Parvovirus (PPV)
Testing product for both porcine and bovine viruses
Basic Microbiology
MCB
WCB
Bacteriostasis/Fungistasis (B & F)
Sterility (Direct Inoculation Method (EP, USP, JP and 21 CFR)
Endotoxin (LAL)
Mycoplasma PCR
Direct Culture and DNA Staining Test for the Detection of Mycoplasmas
TEM Examination of Cell Cultures (200 Cell profiles)
MCB
WCB
In vivo tumorigenicity
MCB
WCB
In vivo Oncogenicity
MCB
WCB
Additional Testing:
EPCB
EPCB
EPCB
EPCB