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Linea 1 Human iPSC Line, Female

RUO human iPSC line, frozen, derived from the Linea 1 GMP master cell bank

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Linea 1 Human iPSC Line, Female

RUO human iPSC line, frozen, derived from the Linea 1 GMP master cell bank

From: 2,099 USD
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RUO human iPSC line, frozen, derived from the Linea 1 GMP master cell bank
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Product Advantages

  • Reduce early-stage development costs with Linea 1 RUO for discovery and process optimization
  • Enable a smoother transition to clinical applications with matched RUO and GMP starting materials
  • Minimize development risk with full traceability and comprehensive qualification

What's Included

  • Linea 1 Human iPSC Line, Female, RUO
Products for Your Protocol
To see all required products for your protocol, please consult the Protocols and Documentation.
  1. mTeSR™1
    mTeSR™1

    cGMP, feeder-free maintenance medium for human ES and iPS cells

Overview

Seamlessly advance your cell therapy program from bench to clinic with a matched pair of good manufacturing practice (GMP) and research-use-only (RUO) human iPSC lines. Linea 1 RUO was created by generating a new master cell bank from the Linea 1 GMP master cell bank and allows you to optimize early research and process development at a lower cost before transitioning to the GMP line for clinical manufacturing.

LineaBio’s Linea 1 Human iPSC Line, Female, GMP was derived from primary human tissue from a healthy female donor. The tissue was procured in compliance with 21 CFR 1271 donor eligibility criteria with full commercial consent and manufactured under controlled GMP conditions for reprogramming, expansion, and banking. The line has been extensively characterized, including by whole genome sequencing, to ensure consistency, robust documentation, and suitability for translational use. Linea 1 GMP is certified by the Human Pluripotent Stem Cell Registry (hPSCreg®) and supported by a Type II Drug Master File on file with the U.S. FDA, available to cross-reference via a Letter of Authorization, providing developers with a standardized chemistry, manufacturing, and controls (CMC) data package that can be referenced in regulatory submissions. The matched Linea 1 RUO iPSC line has been comprehensively assessed to confirm comparability, providing a straightforward path from Linea 1 RUO to Linea 1 GMP that reduces cell line development costs.

Together, the matched Linea 1 RUO and GMP iPSC lines provide a consistent, fully traceable foundation for iPSC-derived cell therapy development that minimizes the risk of late-stage process redesigns and regulatory delays, allowing you to confidently proceed from early discovery through commercial manufacturing. Whole genome and whole exome sequence data files are available upon request. Please contact us for pricing.

To be notified when Linea 1 GMP is available to order, please complete this form.
Contains
CryoStor® CS10
Subtype
Frozen
Cell Type
Pluripotent Stem Cells, Pluripotent Stem Cells, Healthy Control
Species
Human
Cell and Tissue Source
Peripheral Blood, Pluripotent Stem Cells
Area of Interest
Cell Line Development, Disease Modeling, Drug Discovery and Toxicity Testing, Infectious Diseases, Neuroscience, Organoids, Stem Cell Biology, Cell Therapy Development
Donor Status
Normal

Data Figures

Table 1. Linea 1 Is Derived from a Healthy Female Donor

Table 1. Linea 1 Is Derived from a Healthy Female Donor

Demographic, health, and genetic characteristics of the Linea 1 donor are compiled based on self-reported information and whole-exome sequencing. Sex was determined by karyotype. Ancestry and HLA haplotype were calculated from combined whole-genome and whole-exome sequencing data. Blood type (ABO/Rh blood group) was determined by next-generation sequencing. Height, weight, and BMI were calculated at the donation facility.

Figure 1. Linea 1 RUO Human iPSCs Demonstrate Characteristic Morphology in Routine Culture

Figure 1. Linea 1 RUO Human iPSCs Demonstrate Characteristic Morphology in Routine Culture

Cryopreserved cells from Linea 1 Human iPSC Line, Female, RUO were thawed and maintained in mTeSR™1 (Catalog #85850/85857) on BioLaminaⓇ BiolamininⓇ 521 MX (MX521) Catalog (#MX521-0501). The resulting iPSC colonies (A) have densely packed cells and (B, C) show multi-layering when ready to be passaged. Cells retain prominent nucleoli and high nuclear-to-cytoplasmic ratios.

Figure 2. Linea 1 RUO Human iPSCs Maintain a Normal Karyotype

Figure 2. Linea 1 RUO Human iPSCs Maintain a Normal Karyotype

(A) G-T-L banding for thawed cells at p19 (n = 20) shows a normal karyotype with no evidence of clonal abnormalities at a band resolution of 600 G-bands per haploid genome. (B) Fluorescent in situ hybridization in a representative p19 iPSC using probes for 20p11 (green) and 20q11.21 (red). 95% of cells examined displayed two sets of two probe signals, indicating no aneusomy of chromosome 20 (n = 200).

Table 2. Single Nucleotide Polymorphism Microarray Analysis Characterizes Linea 1 RUO Copy Number Variants

Table 2. Single Nucleotide Polymorphism Microarray Analysis Characterizes Linea 1 RUO Copy Number Variants

DNA was extracted from a vial of Linea 1 RUO from the master cell bank and subjected to SNP microarray analysis to identify large-scale copy number variants (CNVs). The cells displayed no reportable CNVs, defined as those greater than 400kb in size. Array design, genomics position, genes, and chromosome banding are based on genome build GRCh38/hg3.

Figure 3. Linea 1 RUO Human iPSCs Express Undifferentiated Cell Markers

Figure 3. Linea 1 RUO Human iPSCs Express Undifferentiated Cell Markers

Linea 1 RUO was characterized using flow cytometry for undifferentiated cell markers OCT3/4 and TRA-1-60. (A) Percentage marker expression was quantified 3 passages after thawing from the analyses of two biological replicates. Representative flow cytometry plots are displayed for (B) OCT3/4 and (C) TRA-1-60.

Figure 4. Linea 1 RUO Human iPSCs Demonstrate a High Trilineage Differentiation Capacity

Figure 4. Linea 1 RUO Human iPSCs Demonstrate a High Trilineage Differentiation Capacity

Cells from Linea 1 RUO were split into 3 groups, differentiated using STEMdiff™ Trilineage Differentiation Kit (Catalog #05230), and then subjected to flow cytometry analysis. Two markers for each embryonic germ layer were assessed, and bars represent mean marker expression for each group of cells (n = 2 biological replicates). PAX6 and Nestin confirm differentiation to the ectoderm lineage, NCAM and Brachyury (T) to the mesoderm lineage, and CXCR4 and SOX17 to the endoderm lineage.

Figure 5. Linea 1 RUO and GMP Human iPSCs Are Comparable

Figure 5. Linea 1 RUO and GMP Human iPSCs Are Comparable

To assess comparability between Linea 1 RUO and GMP, (A) the master cell bank for Linea 1 RUO was generated from the same seed lot as Linea 1 GMP and (B) genomic similarity (99.7%) was determined by whole exome and whole genome sequencing, per section 4.3 of the ISSCR’s Best Practices for the Development of Pluripotent Stem-Cell Derived Therapies. (C) When transitioning from Linea 1 RUO to Linea 1 GMP, users should also assess differentiation to their target endpoint and confirm that target and non-target cell attributes are similar between Linea 1 RUO- and Linea 1 GMP-derived cells.

Protocols and Documentation

Find supporting information and directions for use in the Product Information Sheet or explore additional protocols below.

Document Type
Product Name
Catalog #
Lot #
Language
Document Type
Product Information Sheet
Product Name
Linea 1 Human iPSC Line, Female, RUO
Catalog #
200-1102
Lot #
All
Language
English

Applications

This product is designed for use in the following research area(s) as part of the highlighted workflow stage(s). Explore these workflows to learn more about the other products we offer to support each research area.

Research Area
Workflow Stages

Resources and Publications

Educational Materials (11)

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Cell and Gene Therapy: Products and Services for Your Research
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Cell and Gene Therapy: Products and Services for Your Research
Derivation and Applications of Human Pluripotent Stem Cells
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Derivation and Applications of Human Pluripotent Stem Cells
TeSR™-AOF: Designing a Product for the Future
1:18
Video
TeSR™-AOF: Designing a Product for the Future
Panel Discussion: Balancing Speed, Safety, and Scale in hPSC-Derived Therapy Development
54:41
Webinar
Panel Discussion: Balancing Speed, Safety, and Scale in hPSC-Derived Therapy Development
Key Regulatory Considerations for Moving Your Cell Therapy Research to the Clinic
28:34
Webinar
Key Regulatory Considerations for Moving Your Cell Therapy Research to the Clinic
Matched GMP and RUO Human iPSC Lines
19:53
Webinar
Matched GMP and RUO Human iPSC Lines
Differentiation of Human Pluripotent Stem Cells to Immune Cells for Cell Therapy Development
33:26
Webinar
Differentiation of Human Pluripotent Stem Cells to Immune Cells for Cell Therapy Development
Scaling-Up hPSC-Derived Cardiomyocytes for Preclinical and Therapeutic Applications
42:14
Webinar
Scaling-Up hPSC-Derived Cardiomyocytes for Preclinical and Therapeutic Applications
Legal Statement:

These hiPSCs and their modifications (including but not limited to derivatives or differentiated progeny) shall not be used or administered in (1) human subjects for human clinical use; (2) animals for veterinary use for therapeutic, diagnostic, or prophylactic purposes; or (3) any subject in relation to clinical applications, cell therapy, transplantation, and/or regenerative medicines, without limiting the generality of the foregoing. These hiPSCs and their modifications (including but not limited to derivatives or differentiated progeny) may not be used for monetization or commercialization purposes, including without limitation, used to, or with the goal to, perform services or supply products or rights, including in the manufacture of cellular therapies or other therapeutics, for monetary gain or the generation of royalties, revenues, sales, or other valuable consideration. For clarity, these hiPSCs and their modifications (including but not limited to derivatives or differentiated progeny) may not be used for screening compounds, antibodies, proteins, or peptides, except for the purposes of target discovery, target validation, or assay development, provided such activities and the results of such activities are not further used for monetization or commercialization purposes. For clarity, and without altering the restrictions above, the following uses of this line are within the scope of this Limited Use License: Thawing, expansion, banking, differentiation, gene editing, and characterization of the line and its differentiated progeny for the customer's own internal research use, including development and optimization of differentiation and manufacturing processes. Evaluation of the line and its differentiated progeny as a candidate starting material for a future cell therapy program, including feasibility, potency, and comparability work. In this use the line is the subject of the assessment rather than a system used to screen or validate a drug candidate, and the restrictions above are directed at the latter. Research studies in non-human animals, including engraftment, biodistribution, and safety assessment, where the purpose is research rather than veterinary treatment, diagnosis, or prophylaxis. Publication and presentation of results generated with the line. The restrictions above are directed at resale or transfer of the cells to a third party, provision of services to third parties for consideration using the cells or their progeny, use of the cells to screen compounds, antibodies, proteins, or peptides in support of a therapeutic that will be commercialized, and any administration to humans. They are not directed at a customer's internal research use of the line to evaluate and develop it as a candidate starting material for a product the customer intends to manufacture from GMP material. It may be possible to obtain a further license for the prohibited uses referred to in this Limited Use License. Please contact iPSCrequests@stemcell.com for more details. PRODUCTS ARE FOR RESEARCH USE ONLY AND NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES UNLESS OTHERWISE STATED. 

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