iPSC Manufacturing
uBriGene has years of experience in developing cell therapy products, manufacturing GMP cell therapy products and well-rounded QA and QC systems to meet regulatory requirements. We provide clients with CDMO services such as stem cell production technique development, manufacturing, quality testing, and IND application documentation.
We provide one-stop services including GMP prokaryotic cell bank construction, GMP Plasmid construction, dsDNA, sgRNA, and iPSC cell bank construction.
Production Service
uBriGene’s stem cell single-use production process involves a dedicated suite per patient per lot, which avoids the possibility of cross-contamination. Our stem cell preparation platform is capable of large-scale production and quality control of stem cells from multiple tissue sources, including mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs). The scope of our services include stem cell separation, stem cell bank construction, technique development, production scale-up, analytical method development and quality research, clinical sample production and release, as well as commercial production.
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Stem cell product manufacture consulting
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Stem cell separation, verification, bank construction, product quality inspection and cryopreservation
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Stem cell production technique development, linearly expand production processes
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Stem cell production and quality control for the entire production process
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IND application filing
Production Workflow
gRNA Process Workflow
dsDNA Process Workflow
Production Technique Highlights
Custom-made isolators that adopt the "Quality by Design" concept
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Custom-made isolators that adopt the "Quality by Design" concept
Grade A production environment; single use, fully enclosed production techniques
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Single-use, fully enclosed production techniques effectively prevent contamination and cross-examination
Well-developed QA, QC systems ensure traceability and compliance to regulations
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Safer, more effective and more convenient
Extensive experience in manufacturing cell therapy products
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Extensive experience in manufacturing cell therapy products
Quality Control and Quality Assurance
uBriGene's one-stop gene therapy drug CDMO service platform has rigorous and professional QA and QC teams. We help you with developing testing methods for gene therapy products to meet the testing requirements of all GMP projects. Some testing items and methods are listed below.
gRNA Quality Control
gRNA Stability Test
dsDNA Quality Control
dsDNA Stability Test
