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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: / Investigator:
Email:
Billing Address:
Submitted by: / Date Submitted // / PO #:
Shipping Address:
Zip: / State: / City:
Fax: / Tel: / Ext:

Type of Cells: HumanAnimal

PrimaryImmortalTransformed/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:

AdherentNon-adherent

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Identity Testing

Karyotyping MCB WCBEPCB

Genetic profiling (STR) MCB WCBEPCB

Total viable cells/vial MCBWCBEPCB

Cell viability (post-bank thaw) MCB WCBEPCB

Isoenzyme electrophoresis MCBWCBEPCB

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Glucose-6-phosphate dehydrogenase (G6PD)

Lactate dehydrogenase (LD)

Malate dehydrogenase (MD)

Nucleoside phosphorylase (NP)

Aspartate aminotransferase (AST)

Peptidase B (PepB)

G-Protein coupled receptors (GPCR)

cAMPphosphodiesterase (cAMP)

Protein kinase (PK)

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Purity

In vitro adventitious virus testing MCBWCBEPCB

In vivo adventitious virus testing MCBWCBEPCB

In vitro Assay, Detection of porcine Viral Contaminants using PPK cells According to 9CFR

MCBWCBEPCB

F-PERT Assay MCBWCBEPCB

Retrovirus 293 Co-cult (5 Passages, FPERT End-point) MCBWCBEPCB

PCR testing for human viruses and Mycoplasma for MCB WCBEPCB

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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

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)

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PCR testing for bovine virusesMCBWCBEPCB

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Bovine viral diarrhea virus (BVDV)

Bovine parvovirus (BPV)

Bovine adenovirus (BAV)

Bluetongue virus (BTV)

Bovine respiratory syncytial virus (BRSV)

Reovirus (RV)

Rabies virus

Bovine Herpes Virus I (BHV I)

Bovine Herpes Virus IV (BHV IV)

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PCR testing for porcine virusesMCBWCBEPCB

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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

Swine vesicular disease (SVD)

Vesicular exanthema (VE)

Vesicular stomatitis

Porcine Circovirus-1 and 2 (B/PCV1)

Swine hepatitis E Virus (HEV)

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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 MicrobiologyMCBWCBEPCB

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)MCBWCBEPCB

In vivo tumorigenicity MCB WCBEPCB

In vivo Oncogenicity MCBWCBEPCB

Additional Testing: