GMP grade media supplement for cell therapy workflows.
Key Product Details
Features:
Small donor pool sourced, GMP-compliant human AB serum designed for clinical cell therapy workflows. Available in 100mL Bottle (HABS001-GMP-100mL) or 50mL bag (HABS001-GMP-50B).
Key Benefits:
Bottle format used to formulate 2 liters of GMP Human T Cell Media at 5% supplementation
Bag format conveniently used to formulate 1 liter of GMP Human T Cell Media at 5% supplementation through welding
cGMP, Xeno-free, and testing is compliant with requirements outlined in 21 CFR 610.40
Extensive viral testing done at the donor and pool levels
GMP Human AB Serum is collected from a maximum of sixteen (16) healthy male donors of the AB serotype at FDA-licensed facilities in the United States. This material is defibrinated from source plasma AB using therapeutic grade recombinant human Thrombin. All donor units are tested for viral markers and found to be non-reactive or negative per 21 CFR 610.40 guidelines. GMP Human AB Serum is 0.1 μm sterile filtered, manufactured xeno-free, and does not contain non-human animal-derived components. GMP Human AB Serum is available in a 100 mL bottle format or 50 mL bag format.
Kit Contents for GMP Human AB Serum
100 mL Bottle of GMP Human AB Serum (HABS001-GMP-100ML).
Product Specifications for GMP Human AB Serum
Species
Human
Formulation
Liquid
Osmolality
260-350 mOsm/kg
Sterility Testing
Tested following USP <71> sterility guidelines.
Cell Culture Testing
Donor Level Viral Testing: HBsAg, Anti-HCV, Anti-HIV-1/2, Syphilis, HIV p24 Ag, HBV-NAT, HIV-NAT, HCV-NAT, Anti-HTLV I/II, Anti-HBc IgM, Anti-HBc IgG, Parvo B19 DNA NAT, HAV RNA NAT, Zika RNA NAT, West Nile Virus NAT, Chagas. Pool Level Viral Testing: HBcAB, HTLV I/II, West Nile Virus, Chagas.
Limitations
For preclinical, or clinical ex vivo use
This reagent should not be used beyond the use by date indicated on the CoA
Results may vary due to variations among primary T lymphocyte populations derived from different donors
Scientific Data Examples for GMP Human AB Serum
T cells cultured in GMP Human T Cell Media are viable and undergo robust expansion.
Purified CD4+ and CD8+ T cells were cultured in a 6M G-Rex® Bioreactor in GMP Human T Cell Media (Catalog # CCM038-GMP-1L) with 10 ng/mL of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-GMP), 10 ng/mL Recombinant Human IL-15 GMP Protein (Catalog # BT-015-GMP), and 5% GMP Human AB Serum (Catalog # HABS001-GMP-100ML). Activated T cells were left untreated (No TD) or transduced with Lentivirus (TD) to express CD19-CAR and eGFP. After 8 total days in culture, cells were assessed for viability (A) and cell density (B). Data is the average of 5 T cell donors with error bars ± SD.
GMP Human T Cell Media supports T cell editing with Lentivirus.
Purified CD4+ and CD8+ T cells were cultured in a 6M G-Rex® Bioreactor in GMP Human T Cell Media (Catalog # CCM038-GMP-1L) with 10 ng/mL of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-GMP), 10 ng/mL Recombinant Human IL-15 GMP Protein (Catalog # BT-015-GMP), and 5% GMP Human AB Serum (Catalog # HABS001-GMP-100ML). Activated T cells were left untreated (No TD) or transduced with Lentivirus (TD) to express CD19-CAR and eGFP. After 8 total days in culture, cells were assessed for expression of the inserted cargo CD19-CAR by staining with CD19 recombinant Fluorokine (Catalog # ATM9269) by flow cytometry (A). Total viable edited cells were calculated by multiplying total live cells by % of CD19-CAR+ (B). Data is the average of 5 T cell donors with error bars ± SD.
GMP Human T Cell Media supports generation of TSCM and TCM cells with low PD-1 expression.
Purified CD4+ and CD8+ T cells were cultured in a 6M G-Rex® Bioreactor in GMP Human T Cell Media (Catalog # CCM038-GMP-1L) with 10 ng/mL of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-GMP), 10 ng/mL Recombinant Human IL-15 GMP Protein (Catalog # BT-015-GMP), and 5% GMP Human AB Serum (Catalog # HABS001-GMP-100ML). Activated T cells were left untreated (No TD) or transduced with Lentivirus (TD) to express CD19-CAR and eGFP. After 8 total days in culture, cells were assessed for CD4+ (A) and CD8+ memory cell subsets (B) and expression of exhaustion marker PD-1 (C). T cell memory subsets are gated on CD45RA and CCR7, as stem cell memory (TSCM ,CD45RA+ CCR7+), central memory (TCM, CD45RA- CCR7+), effector memory (TEM, CD45RA- CCR7-), and effector (Teff, CD45RA+ CCR7-). Data is the average of 5 T cell donors with error bars ± SD.
T cell phenotype is maintained in fresh and pre-made media stored at 4 °C for at least 5 weeks.
Xeno-Free GMP Human T Cell Media (CCM038-GMP-1L) was formulated with 5% human AB Serum (HABS001-GMP-100ML) and 10 ng/mL of IL-7 (BT-007-GMP) and IL-15 (BT-015-GMP) cytokines. Media was either used fresh or stored at 2-8 °C for 7-35 days prior to use in human T cell culture. T cells were expanded with a T cell activator in a G-Rex 6M bioreactor for 7 days. Frequency of CD4+ or CD8+ T cells (A), CD4+ T cell phenotype (B), and CD8+ phenotype (C) after 7 days in culture are shown. T cell phenotype is gated on CD45RA and CCR7. Data is the average of 3 purified T cell donors with error bars ± SD.
T cell viability and growth are equivalent in fresh and pre-made media stored at 4 °C for at least 5 weeks.
Xeno-Free GMP Human T Cell Media (CCM038-GMP-1L) was formulated with 5% human AB Serum (HABS001-GMP-100ML) and 10 ng/mL of IL-7 (BT-007-GMP) and IL-15 (BT-015-GMP) cytokines. Media was either used fresh or stored at 2-8 °C for 7-35 days prior to use in human T cell culture. T cells were expanded with a T cell activator in a G-Rex 6M bioreactor for 7 days. T cell viability (A), cell density (B), and fold expansion (C) after 7 days in culture are shown. Data is the average of 3 purified T cell donors with error bars ± SD.
T cell phenotype is maintained in fresh and pre-made media stored at 4 °C for at least 5 weeks.
Xeno-Free GMP Human T Cell Media (CCM038-GMP-1L) was formulated with 5% human AB Serum (HABS001-GMP-100ML) and 10 ng/mL of IL-2 (BT-002-GMP) cytokine. Media was either used fresh or stored at 2-8 °C for 7-35 days prior to use in human T cell culture. T cells were expanded with a T cell activator in a G-Rex 6M bioreactor for 7 days. Frequency of CD4+ or CD8+ T cells (A), CD4+ T cell phenotype (B), and CD8+ phenotype (C) after 7 days in culture are shown. T cell phenotype is gated on CD45RA and CCR7. Data is the average of 3 T cell donors with error bars ± SD.
T cell viability and growth are equivalent in fresh and pre-made media stored at 4 °C for at least 5 weeks.
Xeno-Free GMP Human T Cell Media (CCM038-GMP-1L) was formulated with 5% human AB Serum (HABS001-GMP-100ML) and 10 ng/mL of IL-2 (BT-002-GMP) cytokine. Media was either used fresh or stored at 2-8 °C for 7-35 days prior to use in human T cell culture. T cells were expanded with a T cell activator in a G-Rex 6M bioreactor for 7 days. T cell viability (A), cells density (B), and fold expansion (C) after 7 days in culture are shown. Data is the average of 3 purified T cell donors with error bars ± SD.
Preparation & Storage
Shipping Conditions
The product is shipped with dry ice or equivalent. Upon receipt, store it immediately at the recommended temperature.
Storage
Store the unopened product frozen at ≤ -10 °C. See Use by Date on the Certificate of Analysis.
