From Research To Market
We have been a market leader in innovative analytical solutions for oligonucleotides for more than two decades. We offer high-end analytical solutions for oligonucleotides from R&D and early therapeutic development to clinical and commercial applications.
Release Testing and Characterization of Oligonucleotides
We offer a wide array of in-house analytical tests for the release and characterization of both oligonucleotide drug substance and drug product. Services are performed under cGMP and non-GMP, based on customer requirements – but always according to the highest quality standards.
We are the go-to analytics partner for high-resolution LC-MS analyses in the Pharma and Biotech industries worldwide.
Since 2016, we have been FDA-inspected for the release of commercial oligonucleotide drugs.
Our oligonucleotide characterization services include impurity profiling, structural analysis and characterization and qualification of primary reference standards.
Typical analytical methods for oligonucleotide analysis offered by BioSpring include:
- MS/MS Sequencing
- Karl-Fischer Titration
- Endotoxin Testing (LAL Assay)
- Bioburden Testing (TAMC/TYMC)
- UV-Vis Spectrum
- Impurity Profiling
- Extractable Volume
- Particulate Matter Testing
- Container Closure Integrity
- Density Determination
Analytical Method Development & Validation
We develop individualized analytical solutions for each and every oligonucleotide. For more than two decades, our team of analytical experts has developed, implemented, optimized and validated hundreds of sequence- and structure-specific high-resolution methods.
Working with cutting-edge analytical equipment from all leading manufacturers additionally allows for an efficient transfer of analytical methods to BioSpring.
For commercial and clinical applications, we validate these methods using a customized, stage-appropriate approach according to ICH guidelines.
Our analytical development and validation capabilities and experience go far beyond release, stability, and characterization testing for oligonucleotides, and also include: Raw material method development and validation, high-resolution LC-MS(/MS) method development and validation, in vitro bioassay development and validation, and much more.
Our Analytical Development & Validation Services
- Development and validation of purity- and stability-indicating analytical methods for oligonucleotide drug substance and drug product
- Development and validation of high-resolution LC-MS methods
- Cutting-edge characterization methods for oligonucleotides
- In-house synthesis of standards and oligonucleotide-specific impurity markers for method development/testing for specificity
- Forced degradation studies
- In-use and solution stability studies
- Establishment of validation parameters and specifications
- Development and validation of analytical methods for raw materials, including for customer-specific and customized raw materials
- In vitro bioassay development and validation
- A stepwise validation approach adapted to our clients’ therapeutic program stages
- Analytical validation programs for commercial products
Stability Studies for Oligonucleotide Drug Substance and Drug Product
Oligonucleotides are biopolymers that are sensitive to various environmental factors such as radiation, temperature, water, salt, oxidation, and pH.
The stability of oligonucleotides is one of the key determinants for drug safety and efficacy. A prerequisite for stability studies is a stability-indicating analytical method.
We offer stability studies for all development stages of your program. These studies are performed for drug substance and drug product under non-GMP or cGMP (according to ICH guidelines), as applicable.
- On-site sample storage according to ICH conditions
- Stability studies for commercial oligonucleotide drug substance and product
- Long-term cGMP and non-GMP stability studies for oligonucleotide drug substance and product
- Customized and phase-appropriate stability study design
- In-use and solution stability studies
- Microbial and chemical hold-time studies
- Forced degradation and stress tests
Additional Analytical Services
- Reference standard characterization, including a variety of structural characterization tests
- Dose-formulation analysis
- Characterization of oligonucleotides in complex formulation
- Physicochemical characterization of oligonucleotides in solution, e.g. by DSC
- In vitro bioactivity assays