iPSC Manufacturing Services and Products
for Institutions

Features of I Peace Clinical-grade iPSCs

High Quality

  • Quality management system compliant with ICH Q7
  • Donor screening in accordance with 21 CFR 1271
  • GMP documentation including batch records
  • Traceability of reagents and materials

High level of custom manufacturing

  • Integrated support from PoC (proof of concept) to final product manufacturing to preparation of regulatory submission
  • Flexible manufacturing solutions
  • Preclinical supporting technologies such as drug discovery research using iPSCs available

Global Business Use

  • Simple licensing structure
  • Obtained a license to manufacture specified cell processing products (Japanese Ministry of Health, Labor and Welfare)
  • Compliant with ICH Q7 (Global Guideline)
  • Processes approved by an independent IRB (Ethics Review Board) in the U.S.

Experienced Team

  • All of our manufacturing staff have Clinical Cell Manufacturing certification
  • Highly trained and experienced in iPSC manufacturing

Clinical-grade iPSCs

We manufacture and supply high quality iPSCs aiming to make clinical-grade iPSCs accessible to all

Off-the-shelf lines

  • Multiple GMP-grade iPSC lines available
  • Research-grade lines established from above available
  • Quick contracting process
  • Established with integration-free methods

Custom manufacturing

  • Lead time as short as 3 months
  • iPSC manufacturing experts
  • Custom manufacturing from client-provided materials and pipeline to source donors
  • Rigorous quality control and quality assurance

GMP-grade iPSC medium

  • I Peace’s original GMP medium ”Puel-i”
  • Japanese Standards of Biological Ingredients (JSBI) compatible
 

I Peace Clinical-grade iPSC manufacturing

Currently, there are very few facilities worldwide that can manufacture clinical grade iPSCs on a contract basis. Having multiple contractors to hedge operational risk is, of course important, but that’s not all that I Peace can offer. 

We support clinical research using iPSCs by simultaneously providing multiple clinical-grade iPSC lines. I Peace’s compact and fully-automated iPSC manufacturing system enables mass production of clinical grade iPSCs from multiple donors in a single room. Increasing the available number of clinical-grade iPSC lines allows our customers to take multiple factors, including differentiation propensity, into account and to select the most appropriate iPSC line for their own clinical research. I Peace’s production facility has a clean room that meets the standards set by the Japanese Ministry of Health, Labor and Welfare, and has been licensed by the Kinki Health and Welfare Bureau to manufacture specific cell products. Skilled technicians with the qualifications of a Clinical Cell Culture Specialist manufacture products strictly following SOPs (Standard Operating Procedures). In addition, all processes of cell production and quality inspection are documented to provide guaranteed traceability. The culture solution used for the production of iPSCs is GMP-grade and does not contain any animal-derived components. By introducing reprogramming genes in a manner that does not damage genomic DNA, we can provide high-quality iPSCs without any residual reprogramming factors.

Research-grade iPSCs

We generate iPSCs for a wide range of research so you can focus on research that only you can do

Off-the-shelf iPSC lines

  • Research-grade lines established from GMP-grade iPSCs
  • Other reseach-grade iPSC lines

Custom projects

  • Lead time as short as 2 months
  • Custom manufacturing of iPSCs and other differentiated cells
  • We can process large number of donor specimens at the same time
  • Deep expertise is behind our 100% success rate

I Peace research-grade iPSCs

I Peace research-grade iPSCs

I Peace has deep expertise in iPSC generation. With several iPSC generation methodologies under our belt, we will propose the most optimal method with the shortest lead time depending on cell type and customer needs.

At quickest, we can induce iPSCs in just 14 days, and establish iPSCs in just 1 month. You no longer need to recruit new people or try new experimental kits to establish iPSC lines. Let I Peace handle the iPSC reprogramming so you can focus on research that only you can do.

Our Clients

Research-grade iPSCs
Heart cell therapy
Neural cells

Reach out to us to learn more