Platform

Tap into an established iPSC platform

Accelerate your GMP reprogramming development timeline by 12 months and cut cell line development costs by up to 60 per cent with a trusted partner. Our off-the-shelf iPSC lines are manufactured based on more than a decade of experience by a team of iPSC experts. Our iPSC lines are manufactured in a Grade A/Grade B clean room using a platform which includes reprogramming, clonal selection and banking, in compliance with GMP. All of our lines are made with GMP-compliant reagents with full traceability. Donor starting material is screened and tested according to 21 CFR 1271, and donors have consented to commercial use, to ensure regulatory compliance.

GMP iPSC Reprogramming Platform

1

Donor Material

  • Cord blood or adult peripheral blood (CD34+)
  • Donor medical history questionnaire
  • Donor screening form
  • Viral testing
  • Consented for commercial use

2

Documentation

  • Approved/risk-assessed Bill of Materials
  • QA-reviewed batch record
  • QC test methods
  • QC qualification protocols

3

Reprogramming

  • Sendai virus
  • License to produce with user notice for research use/pre-clinical
  • Path forward to therapeutic license

4

Colony Selection

  • Highly trained operators
  • Redundancy plan
  • Multiple subplots produced from individually selected colonies

5

Expansion and Banking

  • Back-up material cryopreserved throughout expansion
  • GMP seedbanks of multiple clones produced

6

Release Testing

  • Pluripotency
  • Sterility USP<71>
  • Mycoplasma USP<63>
  • Endotoxin
  • Vector clearance
  • STR testing
  • Karyotype

7

Gene Editing

  • Experience with different nucleases
  • Multiplexed editing capabilities
  • Knockout/knock-in
  • Hypoimmune and cloaking strategies

Need a seamless path for the next steps in manufacturing? Learn more about OmniaBio, a technology-driven cell and gene therapy CDMO, and one of our parent companies. OmniaBio can help you with master and working cell banks, process and analytical development and clinical and commercial GMP manufacturing of your drug product.