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Cell-Based Medicinal Products

Quality Assistance has the analytical sciences and technologies needed to support your cell therapy product development, including characterisation, development and validation of analytical methods, stability studies, batch testing and bioanalysis to support PK, biomarker, toxicity and immunogenicity studies.

 



Safety
Endotoxins LAL (kinetic, Gel Clot)
Mycoplasmas q-PCR (in-house multiplex primer)
Viral agents q-(RT)-PCR
General Quality
Appearance Properties after reconstitution
pH / Osmolarity  Zeta potential
Identity – Phenotypic Evaluation
Single protein marker FACS / ELISA / Microscopy*
Multiple protein markers FACS / Luminex / CBA* / ECL (MSD) / Microscopy*
Protein secretion Luminex / CBA* / ECL (MSD) / ELISA / ELISpot
Gene expression q-PCR
Morphology / Distribution  FACS / Microscopy*
Purity
Appearance / morphology / size Microscopy*
Ratio viable / non viable cells / undesired cell types / cell expressing specific markers FACS
Absence of markers / Single marker expression ELISA / FACS / Microscopy*
Multiple protein markers MSD / Luminex / CBA* / FACS / Microscopy*
Product - related impurities
Undesired, undifferentiated, non viable cells FACS
Process - related impurities
Residual solvents (U)HPLC (UV)
Residual proteins (e.g. HCP) and ligands (e.g. antibodies) Luminex / CBA* / ECL (MSD ) / ELISA
Residual chemicals and biochemicals LC-MS  / GC  / ELISA / Colorimetry / (U)HPLC (UV,MS,RI,ELSD,CAD)
Residual inorganic salts (e.g. heavy metals) IEX / ICP / ICP-MS
Medium and buffer components (e.g. BSA, FBS, Antibiotics) Luminex / CBA* / ECL (MSD) / ELISA / Colorimetry / (U)HPLC (UV,MS,RI,ELSD,CAD)
DMSO LC-UV / GC
Differentiation factors (e.g.: cytokines, growth factors) Luminex / ECL (MSD) / ELISA 
Viability
Cell concentration Automated counters / FACS
Cell viability Automated counters / FACS / Colorimetric assays
Biological activity
Biomarkers Luminex / CBA* / ECL (MSD) / q-PCR
Functional protein synthesis
• Receptors
• Metabolism
• Secreted proteins
 
FACS / Microscopy*
Enzymatic assay
Luminex / CBA* / ECL (MSD) / ELISA / ELISpot
Phenotypic evidence of cell function
• Proliferation
• Effects on other cells (e.g. cytotoxicity)
 
FACS
Cell-based assay
Differentiation potential FACS / Enzymatic assay / q-RT-PCR / ELISA / Microscopy
Bioanalysis
Biomarkers ELISA / ECL (MSD) / CBA* / Luminex / q-RT-PCR
Immunogenicity ELISA / ECL (MSD) / SPR (Biacore)
Packaging
Leachables GC / ICP / (U)HPLC
Container Closure System Integrity Bubble test / Dye ingress / Microbial ingress
Cytotoxicity / Biological reactivity  
*Supportive data
 
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Resources

Webinar

Brochure
Coming soon

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The challenge of human mesenchymal stem cells (MSCs) characterisation.
By Sandra Thys, R&D Scientist

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Characterisation of Human Pluripotent Stem Cells (IPSC and ESC) and by-products.
By Valérie Deffontaine, R&D Scientist

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