CBMPs (Cell-Based Medicinal Products)

Quality Assistance provides extensive experience and state-of-the-art EMA/FDA audited facilities, equipment and software for your Cell-Based Medicinal Products development. We have developed and validated robust, precise and accurate methods to characterise CBMPs in terms of identity, purity and potency.

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 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 HS-GC (FID, MS) / (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 ingres
Cytotoxicity / Biological reactivity  
Download the product sheet for more information