Product Shipping & Storage
Shipping Conditions: Dry Ice or LN2
Storage Conditions: LN2 Storage
Upon receipt, immediately transfer each cryovial into the vapor phase of a liquid nitrogen storage Dewar. Cells are viable for at least 2 years when stored under these conditions.
Quality Control Testing
QC testing results provided will consist of the following:
- Attachment from P0 thaw: Typically 15-35% of initial count
- Number of population doublings: Typically 25 (P1 to P3 in BEGM)
- Average population doubling time: Typically 40 ± 10 hours (P1 to P2 cells)
- Transepithelial resistance at 21 days ALI: Typically range from 500 to 2000 Ω (P0 cells starting material, 12mm Transwell™ format)
- Percent ciliated cells at 21 days ALI: Typically >30% of P0 cells
- Percent ciliated cells at 28 days ALI: Typically >40% of P0 cells
- Immunofluorescence at Day 28:
- P0 cells seeded at 350,000 cells/12mm Transwell™ and grown in ALI differentiation medium
- Donor Characteristics Include: Donor age, sex, race, diabetic status, smoking history, alcohol use, and any co-morbidities
- Serology results include (positive or negative): CMV, EBV HBV, HCV, HIV-1, HIV-2, and HLTV-1 and HLTV-2 (only if performed)
- Culture results include (positive or negative): Gram +, Gram -, Mycoplasm and Fungi
CULTURES HAVE A LIMITED LIFESPAN IN VITRO.
Novabiosis guarantees the performance of its cells only if following Novabiosis specific use instructions exclusively, and the recommended protocols are followed. The performance of the cells are not guaranteed if any modifications are made.
Cryopreserved proliferating NhTE-p0 are assured to be viable and functional when thawed and maintained properly.
THESE PRODUCTS ARE FOR RESEARCH USE ONLY and NOT approved for use in humans or clinical diagnostic testing.
WARNING: Primary human cell products are derived from whole human organs, thus should be treated as potentially infectious. Blood samples from the donor are tested and found non-reactive using FDA approved test kits in CLIA certified labs and are testing for the presence of HIV-I/II, Hepatitis B Virus and Hepatitis C Virus. In some cases, but not all, HTLV-1 and 2 are tested and reported.
Test results do not offer complete assurance that HIV-I/II, Hepatitis B Virus, and Hepatitis C Virus are absent. All human sourced products should be handled at the appropriate Biological Safety Level in order to minimize exposure of potentially infectious products.