Analytical Services
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 also 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 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 and 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 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
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Learn more about our Analytical Services
