What is GMPeace?
GMPeace is a one-stop-shop for all your clinical-grade cell project needs. I Peace offers top-quality GMP-compliant iPSC lines available off-the-shelf or custom-manufactured lines to meet your specific needs.
Why GMPeace?
I Peace's GMP cells will take your cell therapy products to the market.
I Peace offers end-to-end GMP cell manufacturing services and tailored solutions to meet your unique iPSC project needs.
Key benefits to choose GMPeace include:
- Industry leading quality standards
- Highly customizable manufacturing
- Global business use
- A team of iPSC science and manufacturing experts
Key features of I Peace GMP iPSC
Fully compliant with 21 CFR 210/211 and ICH Q7. FDA(US) and PMDA (JP) registered and listed /EudraLex compliant. ISO 17025 accredited analytical lab
DMF registered with US FDA for iPSC manufacturing process
US IRB approved IC format / medical history questionnaire
high-quality iPSCs with latest science
Ready to be used commercially in global markets
INTERACT meeting & pre-IND preparation experience. We draft/review/provide necessary documentation.
10+ years of experience as iPSCs scientists and manufacturing technicians
State-of-the Art GMP Manufacturing Facility
I Peace’s manufacturing facility meets all regulations set by the FDA and the Japanese Ministry of Health, Labor and Welfare.
- 3 GMP suites
- Fully compliant with FDA (US, 21 CFR 210/211 and ICH Q7), PMDA (JP), and Eudralex (EU)
- FDA Establishment Identifier of FDA Drug Establishments Current Registration Site 3020167797
- Licensed to manufacture specified cell processing products by the Japanese Ministry of Health, Labor and Welfare
- 3 GMP suites
- Fully compliant with FDA (US, 21 CFR 210/211 and ICH Q7), PMDA (JP), and Eudralex (EU)
- FDA Establishment Identifier of FDA Drug Establishments Current Registration Site 3020167797
- Licensed to manufacture specified cell processing products by the Japanese Ministry of Health, Labor and Welfare
- Audit ready for clients
Custom GMP Cell Manufacturing Service
I Peace’s custom manufacturing service is an end-to-end GMP iPSC and iPSC-derived cell manufacturing service to support all aspects of the GMP cell manufacturing process. Our manufacturing service removes the need to engage multiple companies, accelerating your journey to filing.
I Peace’s Custom Manufacturing & Process Development Services
We meticulously match donors to meet every client’s unique criteria, spanning race, sex, age, blood type, HLA type, viral testing, and more, ensuring the perfect fit.
Our devoted team translates your insights, processes, specifications, and data into the cGMP manufacturing process, ensuring a smooth transition for both clinical and commercial production.
Our cross-functional team of iPSC and manufacturing experts work together to seamlessly transition your cell therapy project from early-phase to commercialization, including process scaling and validation.
Your research, your vision, our expertise. We manufacture your custom and exclusive GMP iPSCs, accelerating your path to the clinic.
Big or small, we can create both GMP master and working cell bank to your specifications.
We expertly tailor your cells through genetic engineering, harnessing the power of CRISPR/Cas9 for both knockout (KO) and knock-in (KI) modifications.
Whether you use our off-the-shelf or your custom generated iPSCs, our team of experts can differentiate to wide range of cell type, including, but not limited to, mesenchymal stem cells (MSCs), hepatocytes, and a variety or neuronal, cardiac, and immune cells.
We integrate regulatory expertise from the beginning, carrying it through the entire clinical and commercialization lifecycle, guaranteeing product consistency and setting the stage for successful regulatory submissions.
iPS cell Custom Production Service
Customize everything from donor criteria to iPSC bank size: I Peace’s iPSC experts trained in GMP will help you find donors and generate iPSCs that match your specific needs.
Manufacture iPSCs
- Non-T cell derived
- ααβ/γδ T cell derived
- clone/pooled
iPSC Expansion
- MCB
- WCB
Evaluation
- GMP compliant
- Characterization Functional Assay
Off-the-shelf GMP iPSC Lines
Our fully characterized GMP iPS cells can ship as quickly as one week from contract finalization.
We can provide GMP iPSC-derived research lines enabling you to check differentiation propensity prior to purchasing our GMP line.
We can provide GMP iPSC-derived research lines enabling you to check differentiation propensity prior to purchasing our GMP line.
- Number of Lines:6 lines from 2 series
- Has experience meeting with FDA, CDE, PMDA
- Used in clinical trials
- Fully consented donors
- Industry-leading quality control release criteria
- Hundreds of MCB vials ready to ship
- Our iPSC cell lines are registered with FDA Drug Master File.
| CNTB series | MUPI series | |
|---|---|---|
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Donor Information |
Asian ethnicity (50s) |
Caucasian ethnicity (20s) |
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HLA Information |
Complete typing information available |
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iPS cell differentiation experience in clinical trials
Our GMP iPSCs have differentiated into cardiomyocytes, NK cells, T cells, hepatocytes, mesenchymal stem cells, and fibroblasts, and used in clinical trials. Please contact us for details.
