Oligonucleotides include mRNA, RNAi pathways, Antisense Oligonucleotides and CRISPR technologies have their own unique analytical challenges.
- Oligonucleotide characterization of Exons (5’ Cap) and Poly (A) Tails (3’End) by Orthoginal Mass Spec
- Purity/Impurity analysis of Starting Materials by LC/MS
- Purity/Impurity analysis by Ion Exchange RP-HPLC and CE
- Oligonucleotide identification by Reverse Transcription (RT) Sanger Sequencing
- Total RNA analysis by Spectroscopy
Oligonucleotide formulations often include liquid nanoparticle technology with polyethylene glycol (PEG) adding to the analytical complexity. We have developed the following analytical methodology to characterize the lipid and drug product:
- % RNA encapsulation by Ribogreen
- Lipids by HPLC-CAD
- Particle Size and Dispersity by Light Scattering
Product testing
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Services
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Equipment
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- RNA/DNA Identity
- 2D/3D structure assessment
- Purity
- Related Substances
- Excipients
- Heavy metals
- Residual solvent, pH, osmolality, density
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- GMP and GLP method validation
- Forced Degradation studies
- Stability studies
- Vendor qualification of amidites
- Adsorption to surfaces: vials, analytical glass, packing
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Purification
- Capillary electrophoresis
- U/HPLC & GC
- Isoelectric focusing
- Size-exclusion
Detection
- LC/MS and LC-MS/MS
- Xevo-QTOF & TripleQuad
- NMR
- ICP-OES
- XRPD
- SDS-PAGE, SDS-CGE
NGS
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Eurofins BioPharma Product Testing Netherlands is a GMP-accredited laboratory that supports the development and optimisation of pharmaceutical products including raw materials, NCE’s, generics, peptides, biologicals, biosimilars and vaccines. We offer flexible and high quality Laboratory Testing services; customized GMP Manufacturing services; and R&D support. Our services consist of genomic, molecular biological and (bio)chemical analyses, and range from early method development through and onto validation, and support in clinical and commercial phases.
Eurofins BioPharma Product Testing Netherlands is recognized as the benchmark for quality and integrity by going further for our customers. This includes having a track record performing root cause analyses to solve issues, develop custom made assays and provide advice in pharmaceutical product testing.
Why choose Eurofins BioPharma Product Testing Netherlands
- Great flexibility. Our focus on small scale projects allows all flexibility you need.
- Single-point-of-contact. With a wide array of services internally available, all communication is centralized.
- Complete service portfolio. Many additional chemical, microbiological and ancillary services performed in GMP certified, WHO prequalified and FDA approved labs.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.
If you want to discuss your project or request a quotation, feel free to contact us.
