BioSpring analytical laboratory
Analytical expertise

Analytical Services for Therapeutic Oligonucleotides

Analytical support for therapeutic oligonucleotide programs, from method development to GMP release testing and commercial supply.

Discuss your project

Analytical expertise across your program

BioSpring supports method development, validation, release testing, stability studies, impurity characterization and bioanalysis. The analytical scope is tailored to your molecule, development stage and the intended use of the data.

Analytical and manufacturing teams work together to keep methods, materials and data connected as your program progresses.

Analytical support across your program

Scope

Drug substance and drug product

Methods

Development, validation and transfer

Quality control

Release and stability testing

Characterization

Impurities and comparability

Bioanalysis

Oligonucleotides in biofluids and tissues

Continuity

Early development through commercial supply

Why analytics matter

Analytical strategy is part of development strategy

Analytical requirements evolve as an oligonucleotide moves from early development into clinical and commercial supply. Methods used for screening or feasibility work may need further development, qualification or validation to support identity, purity, impurity control, stability and batch release.

BioSpring helps align methods, specifications and analytical data with your molecule, development stage and manufacturing process.

Analytical methods and QC services

From method development to release and stability testing

BioSpring develops, validates and transfers analytical methods for oligonucleotide drug substance and drug product. The scope is adapted to your molecule, development stage and regulatory requirements.

Impurity profiling and characterization

Understanding what matters for quality and comparability

Oligonucleotide impurity profiles can be influenced by synthesis chemistry, purification strategy, modification pattern, scale and process changes. Understanding these profiles supports development decisions and regulatory communication.

BioSpring uses analytical techniques including LC-MS and LC-MS/MS to support impurity quantification, characterization and comparability assessments.

Analytical understanding

  • Impurity quantification and profiling
  • Oligonucleotide characterization
  • Comparability assessments following process changes

Explore Characterization Services →

Phase-appropriate analytical support

Methods that mature with your program

The analytical scope should reflect the intended use of the data. BioSpring supports a stepwise approach from method development and qualification to validation, release testing and stability studies.

Development-stage programs

Develop and qualify methods around your molecule, sample type and analytical objective, with performance requirements appropriate to the development stage.

Plan method development and transfer with later validation in mind. BioSpring’s approach considers ICH Q14 and ICH Q2(R2), where applicable.

Explore Method Development & Transfer →

Clinical and commercial programs

Validate methods for their intended use and define release and stability testing for oligonucleotide drug substance and drug product.

Generate analytical data to assess batch quality and stability, with the testing scope aligned to the program’s specifications and quality requirements.

Explore Release & Stability Testing →

Bioanalytical services

Quantifying oligonucleotides in biofluids and tissues

BioSpring offers extraction, quantification and profiling of oligonucleotides in relevant biological matrices. Bioanalytical services support preclinical and clinical development, with the scope adapted to the molecule, matrix and study requirements.

Bioanalytical capabilities

  • Extraction of oligonucleotides from biofluids and tissues
  • Quantification by hELISA, LC, LC-MS, LC-MS/MS and qPCR
  • Metabolite identification and profiling
  • Non-GMP and GMP analyses
  • Method validation according to ICH M10, where applicable

Explore Bioanalytical Services →

Integrated with manufacturing

One analytical partner across development and supply

BioSpring’s analytical and manufacturing teams work together to assess how process development and scale-up affect an oligonucleotide’s quality profile. Analytical input supports decisions on impurity control, comparability, release testing and stability.

Where BioSpring also manufactures your oligonucleotide, the teams can coordinate analytical methods and testing with the manufacturing process and supply requirements.

Connected manufacturing support

Explore Manufacturing Services →

When clients work with BioSpring analytics

Common project situations

Start with the decision your analytical data need to support. We can help define a scope for a specific development question or for ongoing testing as your program progresses.

Tell us about your molecule, development stage, available samples and methods, and the milestone you are working toward. These details help our team assess the testing scope and timeline.

Where we can support you

  • Preparing an analytical package for GMP manufacturing
  • Assessing comparability after scale-up or process changes
  • Planning clinical or commercial release and stability testing
  • Characterizing an oligonucleotide or investigating impurities
  • Quantifying oligonucleotides in biofluids and tissues

Ready for what's next? 

How we start
1
You share the basics
Molecule type, sample or matrix, development stage, analytical objective and available methods.
2
We evaluate your requirements
Our analytical experts review methods, sample needs, quality requirements and timelines.
3
You receive a proposal and timeline
A defined scope of work, deliverables and costs.
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Discuss the next step for your program

Define the analytical scope, sample requirements and timeline with our team.

Learn more about our solutions

Explore More

Explore our analytical services

View analytical services overview
Method development and transferMethod validationRelease and stability testingCharacterization servicesBioanalytical services for oligonucleotides

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