Nucleic Acid Analytics and Quality Control
BioSpring is the industry‘s trusted partner for release testing, stability studies, and characterization of oligonucleotides (API and Drug Product). We offer tailor-fit solutions adapted to your therapeutic program‘s stage from R&D and early therapeutic development to market approval and beyond.
- Analytical Quality by Design (AQbD) meeting ICH Q14 requirements
- Advanced state-of-the-art methods like high-resolution LC-MS, LC-MS/MS, MS/MS sequencing, and NGS
- Flexible stepwise validation approach - early stage to commercial
- Analytical methods for raw materials including custom raw materials
- 9 laboratories and teams for late-stage programs, analytical method development, microbiology and bioanalytics
Supporting the entire drug development process.
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 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:
- 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
- FT-IR
- CD
- DSC
- NMR
- UV-Vis Spectrum
- DVS
- TGA
- Solubility
- Impurity Profiling
- 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.
Method Development & Validation
BioSpring uses over two decades of know-how and experience paired with the most advanced analytical equipment available on the market to develop robust analytical solutions adapted to your unique molecules. Working with cutting-edge analytical equipment from all leading manufacturers allows also for an efficient transfer of analytical methods to BioSpring, if required.
Our analytical development and validation capabilities include:
- Release, stability, and characterization testing for oligonucleotides
- Raw material method development and validation
- High-resolution LC-MS(/MS) method development and validation
- Biochemical and pharmacokinetic assay development and validation
Our team of analytical experts have developed, implemented, optimized, and validated hundreds of sequence- and structure-specific high-resolution methods. For commercial and clinical applications, we validate these methods using a customized, stage-appropriate approach compliant with ICH guidelines.
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
- Biochemical and pharmacokinetic assay 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 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.
Within our 7,000 ft² analytical laboratory space, we offer ICH-compliant stability studies for all stages of your program. These studies are performed for drug substance and drug product under non-GMP or GMP conditions, as applicable.
- Stability studies for commercial oligonucleotide drug substance & product
- On-site sample storage according to ICH conditions
- Long-term GMP & non-GMP stability studies for oligonucleotide drug substance & product
- Customized & phase-appropriate stability study design
- In-use & solution stability studies
- Microbial & chemical hold-time studies
- Forced degradation & stress studies
- High-resolution LC-MS capabilities
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
