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Oligonucleotide Analytics

Oligonucleotide 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, MS/MS sequencing and NGS
  • Flexible stepwise validation approach - early stage to commercial
  • Analytical methods for raw materials including custom raw materials 
Drug Substance and Drug Product

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 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.

Typical analytical methods for oligonucleotide analysis offered by BioSpring include:

Oligonucleotide Drug Substance Release
  • (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. 

Every Oligonucleotide is unique

Analytical 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 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 according to 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 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 developmental stages of your program. These studies are performed for drug substance and drug product under non-GMP or cGMP conditions (according to ICH guidelines), as applicable.

Our Stability Study Solutions:
  • 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 studies
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icon high resolution
High-Resolution LC-MS
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> 5,400 f²
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From Research to Market

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
Unleash the full potential of your next oligonucleotide program! Contact us