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:
- customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
- 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
- regulatory, scientific and technical excellence with a problem-solving approach
- compliance with all applicable EMA, FDA and ICH regulations
- 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 (DETECTION AND QUANTIFICATION)
| Endotoxins |
| Mycoplasma (PCR based methods) |
| Adventitious virus (PCR based methods) |
IDENTITY (PROFILING)
| Single and multiplexed assay biomarker expression |
| Secreted biomarkers |
| Cell morphology |
| Transcriptomic expression analysis |
PURITY (DETECTION AND QUANTIFICATION)
| Viability/Apoptosis |
| Cell phenotype |
| Cell differentiation state |
| Biomarker expression |
IMPURITIES (DETECTION AND QUANTIFICATION)
| Ancillary products |
| Residual inorganic, chemical contaminants |
| DMSO detection and quantification |
| Soluble growth and differentiation factors |
POTENCY AND FUNCTIONALITY
| Biomarkers / Biological active substances |
Functional protein expression
|
Evidence of function and MOA
|
| In vitro assay |
| Immunogenicity and allogenicity |
PACKAGING
| Leachables |
| Container closure system integrity |
| Cytotoxicity/Biological reactivity USP<87> |
Cell-Based Medicinal Products
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