Analytical Services
Release Testing and Characterization of Drug Substance and Drug Product
We make it our daily mission to meet your specifications, offering a wide array of in-house analytical tests for the release and characterization of both oligonucleotide drug substance and drug product. Services are performed either under GMP or non-GMP, based on customer requirements, but always according to the highest quality standards.
Our oligonucleotide characterization services include impurity profiling, structural analysis, and the characterization and qualification of primary reference standards.
Since 2016, we have been FDA-inspected for the release of commercial oligonucleotide drugs. We are also a top provider of high-resolution LC-MS analyses in the pharmaceutical and biotechnology industries worldwide.
Excerpt of analytical methods for oligonucleotide analysis offered by BioSpring include:
Oligonucleotide Drug Substance Release
- UPLC/HPLC
- (LC)-MS
- UV-Vis
- MS/MS Sequencing
- HS-GC-MS
- Karl-Fischer Titration
- Endotoxin Testing (LAL Assay)
- Bioburden Testing (TAMC/TYMC)
- FAAS
- ICP-MS
Oligonucleotide Characterization
- FT-IR
- CD
- DSC
- NMR
- UV-Vis Spectrum
- DVS
- TGA
- Solubility
- Impurity Profiling
Oligonucleotide Drug Product Release
- Extractable Volume
- Particulate Matter Testing
- Sterility
- Osmolality
- Container Closure Integrity
- Density Determination
- Assay
We are the go-to analytics partner for high-resolution LC-MS analyses in the Pharma and Biotech industries wordwide.
Have a question or need a quote? Contact us
Learn more about our Analytical Services
