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GMP iPSC

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.

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We provide one-stop services including GMP prokaryotic cell bank construction, GMP Plasmid construction, dsDNA, sgRNA, and iPSC cell bank construction.

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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.

  • Stem cell product manufacture consulting

  • Stem cell separation, verification, bank construction, product quality inspection and cryopreservation

  • Stem cell production technique development, linearly expand production processes

  • Stem cell production and quality control for the entire production process

  • IND application filing

Production Workflow

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gRNA Process Workflow
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dsDNA Process Workflow
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Production Technique Highlights

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Custom-made isolators that adopt the "Quality by Design" concept

  • Custom-made isolators that adopt the "Quality by Design" concept

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Grade A production environment; single use, fully enclosed production techniques

  • Single-use, fully enclosed production techniques effectively prevent contamination and cross-examination

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Well-developed QA, QC systems ensure traceability and compliance to regulations

  • Safer, more effective and more convenient

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Extensive experience in manufacturing cell therapy products

  • 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
QC Category
QC Category
QC Method
QC Standard
Appearance
Appearance
Visual Inspection
Free of foreign particles, turbidity or precipitates
Sequence identify
Sanger Sequencing
First generation sequencing
Correct sequence P≥98%
Sequence identify
Next-Generation Sequencing
Second generation sequencing after reverse transcription
Correct sequence P≥98%
Concentration
Concenttration
Nanodrop, UV absorbance
Measured value
Biological Activity
Infection Titer
TCID50
VC/IU≤730
Biological Activity
Gene Of Interest Expression Level
Western Blot
Completed by client
Purity
Molecular Weight
MASS
MW±0.5%
Purity
gRNA Purity
OD260/OD280
260 nm/280 nm: 1.8-2.0; 260 nm/230 nm: >1.8
Purity
gRNA Purity
HPLC/CE
Main peak ≥90%
Purity
Protein residue
Protein quantitation assay
MicroBCA
Purity
Residual DNA template
QPCR
Data report
Purity
Residual T7 RNA Polymerase
ELISA
<2ng/mL
Purity
Residual RNasel
ELISA
Data report
Purity
Residual RNase Inhibitor
ELISA
Data report
Chemical property
Osmotic Pressure
Freezing point osmotic pressure
Solvent dependent
Chemical property
pH
pH meter
Solvent pH±0.5
Safety
Sterility
Direct inoculation
Not detectable
Safety
Mycoplasma
QPCR
Not detectable
Safety
Endotoxin
Gel-BDBU
≤ 2 EU/mg (Satisfies U.S. and China IND application requirements)
gRNA Stability Test
Stability Test
Conditions
Re-Testing Time
Attributes Tested
Long-term Stability Test
-80±5
Every 0/1/3/9 months
Physical appearance, concentration, purity
Long-term Stability Test
-80±5
Every 12 months
Full inspections of all quality control attributes
Usage Stability Test
25±2
Every 0/4/24 hours
Physical appearance, concentration, purity
Freeze-Thaw Stability Test
-20±5 freeze-thaw cycles
1/3 time
Physical appearance, concentration, purity
dsDNA Quality Control
Stability Test
Conditions
Re-Testing Time
Attributes Tested
Long-term Stability Test
-80±5
Every 0/1/3/6/9 months
Physical appearance, concentration, purity
Long-term Stability Test
-80±5
Every 12 months
Full inspection of all QC attributes
Usage Stability Test
25±2
Every 0/4/24 hours
Physical appearance, concentration, purity
Freeze-Thaw Stability Test
-20±5 freeze-thaw cycles
1/3 times
Physical appearance, concentration, purity
dsDNA Stability Test
Stability Test
Conditions
Re-Testing Time
Attributes Tested
Long-term Stability Test
-80±5
Every 0/1/3/6/9 months
Physical appearance, concentration, purity
Long-term Stability Test
-80±5
Every 12 months
Full inspection of all QC attributes
Usage Stability Test
25±2
Every 0/4/24 hours
Physical appearance, concentration, purity
Freeze-Thaw Stability Test
-20±5 freeze-thaw cycles
1/3 times
Physical appearance, concentration, purity
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