CBMPs (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
  • Bioanalysis
SAFETY
Endotoxins MONOcyte Activation Test (MAT)
Limulus amoebocyte lysate (LAL)
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
Residual chemicals and biochemicals LC-MS / GC / (U)HPLC (UV,MS,RI,ELSD,CAD) / ELISA / AlphaLISA
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 / (U)HPLC (UV,MS,RI,ELSD,CAD)
DMSO LC-UV / GC
Differentiation factors (e.g.: cytokines, growth factors) Luminex / ECL (MSD) / ELISA / AlphaLISA / Colorimetric assays
BIOLOGICAL ACTIVITY
Biomarkers / Biological active substances Luminex / ECL (MSD) / ELISA / AplhaLISA / 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 / Colorimetric assays
Download the product sheet for more information