Cell & Gene Therapy solutions
Cell & Gene therapies—encompassing viral vectors, genetically modified cells, and mRNA-based treatments—represent a revolutionary set of biotherapeutics. Investigated for their transformative potential to address the root causes of genetic disorders, rare diseases, and complex malignancies, these advanced modalities require highly specialized manufacturing and stringent quality controls. Due to their intrinsic complexity and biological variability, they demand a comprehensive and integrated analytical framework to ensure product consistency, safety, and sustained clinical efficacy.
Our Cell & Gene Therapy track record:
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Stem cells
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CAR-T cells
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NK cells
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PBMCs
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mRNA / saRNA
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Plasmid
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Viral vectors
Advance your Cell or Gene therapy with analytical confidence.
Testing capabilities
General quality
- Appearance
- pH
- Osmolality
Quantity
- Cell viability
- Cell count
Purity
- Percentage of dead cells & undesired cells
- Ratio viability
- MHCII
Characterization
- Multiplex testing / FACS
- Primer & probe design
- Electrochemiluminescence (MSD)
Identity
- Single/ multiple protein markers
- Absence of marker(s)
- Protein secretion
- Gene expression
- Distribution by flow cytometry
- Genetic sequence confirmation - Capping - PolyA
Potency
- Biomarkers (Genetic - Protein)
- ELISA
- Gene expression by RT-qPCR
- Enzymatic assays
- Cell-based assays
- Flow cytometry
- Mixed lymphocyte reaction (MLR) assay
Process related impurities & contaminants
- Host-derived (HCPs, DNA)
- Downstream/ cultured-derived
- Residual solvents/ chemicals/ biochemical/ inorganic salts
- Medium components
- Mycoplasma
- Sterility (outsourced)
- Endotoxins
Key technologies
- Cell Culture
- Electroporation
- Flow Cytometry
- ELISA
- Capillary electrophoresis
- Real-time PCR (RT-qPCR)
- Sequencing (via ohmx.bio, part of anacura group)
- Luminescence/Fluorescence
- Meso Scale Discovery's (MSD); Multi Array technology
- Gas Chromatography
- Liquid Chromatography
- Spectrophotometry
- High-Resolution Mass Spectrometry
All testing capabilities
Synthetic Molecule Solutions
Biological Molecule Solutions
