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How We Work
RUO cell lines are available for basic research purposes and can be accessed through a Material Transfer Agreement (MTA) for a fee. If you are evaluating a GMP iPSC line for clinical use, your journey to obtain lines will follow the steps below.
Data Room
- LineaBio provides access to a data room for due diligence under a confidential disclosure agreement.
- The data room includes complete information on the donor, manufacturing and standard licensing terms for the GMP iPSC line.
Material Transfer Agreement
- MTA is executed. LineaBio ships you vials of RUO cells equivalent to a GMP iPSC line.
- Cells are accompanied by a Certificate of Analysis.
Evaluation
- You evaluate the cell line in your differentiation process.
- LineaBio works closely with you during the evaluation process to provide technical support as needed.
License Agreement
- We negotiate terms to access a GMP iPSC line and execute a License Agreement.
- Both non-exclusive and exclusive license options are available.
Shipping
- We ship vials of the GMP iPSC line to you.
- Cells are accompanied by a Certificate of Analysis and information to cross-reference the drug master file with the FDA.
Product Catalogue
Select the right iPSC line for your drug product
LineaBio’s cell lines include both unmodified iPSC lines and iPSC lines modified with gene editing tools to enhance the utility of therapeutic cells. Starting material for our off-the-shelf iPSC lines includes cord blood (CD34+) and adult peripheral blood (CD34+) from both males and females. Cell lines are provided to industry through non-exclusive and exclusive licenses, using a flexible pricing model, uniquely providing you with full visibility to licensing terms for the GMP iPSC line. Each seedbank is derived from individual colonies (sublots) selected following reprogramming.
GMP iPSC Lines
Linea 1
Status: available today
Donor: adult peripheral blood (CD34+); female; Caucasian; blood type O-positive;
commercial consent and regulatory-compliant (21 CFR 1271)
Gene Editing: none, unmodified
GMP Seedbanks Available (Product Code):
- GMP Seedbank 1 (Item: 014.001, Lot: 24.0157.SB)
- GMP Seedbank 2 (Item: 014.001, Lot: 24.0157.SAF)
- GMP Seedbank 3 (Item: 014.001, Lot: 24.0157.SK)
- GMP Seedbank 4 (Item: 014.001, Lot: 24.0157.SV)
- GMP Seedbank 5 (Item: 014.001, Lot: 24.0157.SX)
- GMP Seedbank 6 (Item: 014.001, Lot: 24.0157.SG
Linea 1 (Hypoimmune)
Status: in development – available 2025
Donor: adult peripheral blood (CD34+); female; Caucasian; blood type O-positive;
commercial consent and regulatory-compliant (21 CFR 1271)
Gene Editing: homozygous double knockout of B2M (HLA-I) and CIITA (HLA-II)
Linea 2
Status: in development – available 2025
Donor: cord blood (CD34+); male; Caucasian; blood type O-positive;
commercial consent and regulatory-compliant (21 CFR 1271)
Gene Editing: none, unmodified
Research-Use-Only (RUO) iPSC Lines
Linea 1
Status: available today
Donor: adult peripheral blood (CD34+); female; Caucasian; blood type O-positive;
commercial consent and regulatory-compliant (21 CFR 1271)
Gene Editing: none, unmodified
Type: GMP-equivalent (derived from GMP seedbanks)
RUO Seedbanks Available (Product Code):
- RUO Seedbank 1 (24.0157.SB.RUO)
- RUO Seedbank 2 (24.0157.SAF.RUO)
- RUO Seedbank 3 (24.0157.SK.RUO)
- RUO Seedbank 4 (24.0157.SV.RUO)
- RUO Seedbank 5 (24.0157.SX.RUO)
- RUO Seedbank 6 (24.0157.SG.RUO)
Linea 2
Status: available today
Donor: cord blood (CD34+); male; Caucasian; blood type O-positive;
commercial consent and regulatory-compliant (21 CFR 1271)
Gene Editing: none, unmodified
Type: GMP donor, non-equivalent (not derived from GMP seedbanks)
RUO Seedbanks Available (Product Code):
- RUO Seedbank 1 (Thu1.A)
- RUO Seedbank 2 (Thu1.E)
Linea 3
Status: available today
Donor: female, cord blood (CD34+)
Gene Editing: none, unmodified
Type: RUO donor, no GMP equivalent available
RUO Seedbanks Available (Product Code):
- RUO Seedbank 1 (IN20164A1T)
- RUO Seedbank 2 (IN20164A6T)
Linea 3 (Hypoimmune)
Status: available today
Donor: female, cord blood (CD34+)
Gene Editing: homozygous double knockout of B2M (HLA-I) and CIITA (HLA-II)
Type: RUO donor, no GMP equivalent available
RUO Seedbanks Available (Product Code):
- RUO Seedbank 1 (IN20164A1T.SQP2.A4)
- RUO Seedbank 2 (IN20164A1T.PL6.G2)