Cell-Based Medicinal Products
Cell-Based Medicinal Products are complex and require state-of-the-art analytical methodologies to evaluate their quality, safety and efficacy. Quality Assistance provides you with the scientific and technical support to develop and/or optimise these methods for use in a GxP-regulated environment.
Throughout non-clinical and clinical development, our experts provide you with the customised solutions in terms of analytical protocols and innovative technologies to help you move your product from discovery to the market place.
Your analytical partner providing:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
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a full range of equipment in Cell Biology, Biochemistry, Chromatography, Mass Spectrometry, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
- Analytical development
- Validation of analytical methods as per ICH guidelines
- Drug Substance/Drug Product characterisation and QC testing
- Stability studies
- Statistical analyses
- Batch testing
- Bioanalytical services
SAFETY
| Endotoxins |
MONOcyte Activation Test (MAT) |
| Mycoplasmas | q-PCR (in-house multiplex primer, commercial kit) |
| Viral agents | commercial q-(RT)-PCR |
IDENTITY – PHENOTYPIC EVALUATION
| Single protein marker | FACS / ELISA / Microscopy* |
| Multiple protein markers | FACS / Luminex / ECL (MSD) / Microscopy* |
| Protein secretion | Luminex / ECL (MSD) / ELISA / ELISpot |
| Cell interactions | Cell based assays |
| Gene expression | q-RT-PCR |
| Morphology | FACS / Microscopy* |
PURITY
| Appearance / morphology / size | Microscopy* |
| Ratio viable / non viable cells / undesired cell types / cell expressing specific markers | FACS / Automated counters |
| Absence of markers / Single marker expression | ELISA / FACS / Microscopy* |
| Multiple protein markers | MSD / Luminex / FACS / Microscopy* |
PRODUCT-RELATED IMPURITIES
| Undesired, undifferentiated, non viable cells | FACS / q-RT-PCR |
PROCESS-RELATED IMPURITIES
| Residual proteins and ligands | Luminex / ECL (MSD ) / ELISA / AlphaLISA / DELFIA |
| Residual chemicals and biochemicals | LC-MS / GC / (U)HPLC (UV,MS,RI,ELSD,CAD) / ELISA / AlphaLISA / DELFIA |
| Residual inorganic salts (e.g. heavy metals) | IEX / ICP / ICP-MS |
| Medium and buffer components (e.g. BSA, FBS, Antibiotics) | Luminex / ECL (MSD) / ELISA / AlphaLISA / DELFIA / U)HPLC (UV,MS,RI,ELSD,CAD) |
| DMSO | LC-UV / GC |
| Differentiation factors (e.g.: cytokines, growth factors) | Luminex / ECL (MSD) / ELISA / AlphaLISA / DELFIA / Colorimetric assays |
BIOLOGICAL ACTIVITY
| Biomarkers / Biological active substances | Luminex / ECL (MSD) / ELISA / AplhaLISA / DELFIA / FACS/ q-RT-PCR / ELISpot |
| 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) • Immune cell activation |
• FACS • Cell-based assay • ELISpot / Luminex / Bioassays |
| Differentiation potential | FACS / Enzymatic assays / q-RT-PCR / ELISA / AlphaLISA / DELFIA / Colorimetric assays |
