Oligonucleotides
Due to their relatively large size as compared to typical small molecule drugs, there are many technical challenges associated with the analysis of oligonucleotides.
With a highly experienced staff and state-of-the-art premises and equipment, Quality Assistance is your partner of choice to overcome your analytical hurdles and facilitate the registration process.
Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.
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 Chromatography, Mass Spectrometry, Biochemistry, 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:
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Analytical development
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Validation of analytical methods as per ICH guidelines
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Characterisation
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Stability studies
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Batch testing
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Bioanalytical services
GENERAL QUALITY
| Appearance / pH / Osmolarity / Properties after reconstitution | |
| Particulate matter | Optical microscopy / Light obscuration / Imaging Particle Analysis |
| Particle size (formulations) | DLS / AF4 (UV, RI, MALLS) |
| Water content / residual moisture (if lyophilised) | (Coulometer) KF titration |
IDENTITY
| Intact oligonucleotide | (U)HPLC (UV, RI, MS) |
| Molecular weight | ESI-MS / MALDI-TOF |
| Nucleotide composition / Sequencing | UPLC (UV, MSE) / MALDI-TOF / MS/MS |
QUANTITY
| Assay | UV / (U)HPLC (UV, MS) / Solpe Spectroscopy (SoloVPE) |
| Absolute oligonucleotide content determination | UV + ICP-MS |
| Determination of extinction coefficient | UV + UPLC (UV) / ICP-MS |
PURITY & INTEGRITY
| Purity profile | IEX / RP-(U)HPLC / HILIC (UV, MS) / (ic)IEF |
| Structure | Circular dichroism (CD) / SEC (UV, RI, ELS, MALLS) |
| Chain length | CE (icIEF, CE-SDS) / IEX / RP-(U)HPLC (UV, MS) / HILIC (UV, MS) / SEC (UV, RI, MALS) |
| Molecular backbone composition (P=S / P=O) | ICP-MS |
| Chemical modifications and degradation patterns | ESI-MS / CGE (UV, LIF, MS) / IEX / RP-(U)HPLC (UV, MS) / SEC-MALS / HILIC (UV,MS) / SDS PAGE |
| Aggregation and particle size distribution patterns | AF4 & SEC-(U)HPLC (UV / RI / MALS) / DLS / Imaging particle analysis |
| Enantiomeric purity | (U)HPLC-UV / GC-MS |
| Counter-ion content (Mass balance) | (U)HPLC (UV, MS) / ICP (OES, MS) |
POTENCY
| Immunoassays | ELISA / ECL (MSD) / Biacore / Octet / FACS |
| Cell-based assays (Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc.) | Different read outs |
PROCESS-RELATED IMPURITIES
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins | LAL (kinetic, end point), Monocyte Activation Test / rFC |
| Elemental Impurities | ICP-MS |
| Residual solvents | HS-GC (FID, MS), HPLC (UV, MS) |
PACKAGING
| Leachables | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
| Container Closure System Integrity | Bubbling / Dye ingress (methylene blue, fluorescence) / Microbial ingress |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
