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Please note that we are not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Stability Testing of Oligonucleotide Drugs

Oligonucleotide drugs constitute therapeutic molecules that target RNA or DNA sequences to control gene expression through specific binding and include ASO (antisense oligonucleotide), siRNA, miRNA, aptamer among others. Because their natural structure is vulnerable to nuclease degradation and chemically unstable systematic stability testing needs to be conducted during drug development. Protheragen BioNucleics focuses on providing high-quality, full-process oligonucleotide drug formulation development services, covering a variety of administration routes and dosage forms to meet different non-clinical and R&D needs.

Oligonucleotide Drug Stability Testing Service

Oligonucleotide drugs represent advanced therapeutics that offer precise targeting capabilities while finding applications in gene silencing and splicing regulation as well as antiviral and anti-tumor treatments among other areas. Since the drug possesses a unique chemical structure stability becomes a crucial evaluation parameter throughout its development process. Researchers use stability testing to assess how oligonucleotides degrade and determine their shelf life across various storage, transportation and use conditions including temperature humidity light and pH levels. Stability testing verifies oligonucleotides maintain safety standards alongside their effectiveness and consistent quality. Our oligonucleotide drug stability testing services encompass:

Test type	Description
Thermal Stability	Simulate the degradation of drugs under high temperature conditions (such as 40°C, 60°C)
pH Stability	Test its stability in different pH environments (such as pH 2~9)
Light Stability	Simulate the degradation under sunlight or fluorescent light (in accordance with ICH Q1B)
Freeze-thaw Stability	The impact of multiple freeze-thaw cycles on drug quality
Long-term Storage Stability	Stability evaluation under storage conditions such as room temperature, refrigeration, and freezing
Solution Stability	Degradation after storage in different solvents (such as PBS, plasma)
Stability in Biological Samples	Stability analysis in plasma, serum, tissue homogenate, etc.
Analysis of Degradation Products	Analyze the type and content of degradation products using LC-MS/MS and other methods

Detection Methods

High performance liquid chromatography (HPLC)
Liquid chromatography-mass spectrometry (LC-MS/MS)
UV-Vis spectroscopy
Capillary electrophoresis (CE)
qPCR / RT-PCR (for functional activity detection)

Additional Services

Sample analysis method development and validation
Stability study plan design
Stability testing under ICH Q1A (R2) guidelines
Data statistics and report writing (including complete reports in compliance with registration applications)
Customizable accelerated, long-term, and periodic testing plans

Necessity of Stability Testing of Oligonucleotide Drugs

Meet Regulatory Requirements

All drug registration applications require the provision of systematic stability research data as an important basis for quality control and expiration date setting.

Ensure Drug Quality and Safety

Oligonucleotides are easily degraded due to environmental changes, which may lead to reduced efficacy or the production of toxic impurities. Stability testing helps identify degradation pathways and optimize formulation processes.

Guide Setting of Storage and Transportation Conditions

Clearly determine the stability of drugs under conditions such as room temperature, refrigeration, and freezing, and reasonably formulate storage specifications and transportation plans.

Support Formulation Development and Packaging Design

Different prescriptions and packaging materials have a significant impact on stability, and test results can be used to select better formulation processes and packaging materials.

Ensure Stable Supply of Non-clinical Trial Drugs

Drug quality must be consistent during non-clinical research, and stability studies help to formulate reasonable drug use cycles and replenishment plans.

Service Highlights

Professional Team & technology Platform: A team with rich experience in nucleic acid drug research and development, equipped with advanced instruments such as LC-MS/MS, qPCR, HPLC, CE, etc.
Strong method Development Capabilities: Provide full-process services from method development, validation to application to meet the detection needs of different molecular types and modification methods
Diversified Test Conditions: Covering a variety of practical application scenarios such as thermal stability, light, freeze-thaw, pH, long-term storage, etc.
Customized Service: Flexible customization of test solutions based on customer project stage, sample quantity, and research purpose

Application Areas

Non-clinical drug research
Preparation of IND/NDA application materials
Setting of drug storage and transportation conditions
Establishment of drug quality control standards

Protheragen BioNucleics is a specialist organization focused on oligonucleotide drug development and formulation services. Contact us to realize your research and therapeutic potential.

Our services and products are exclusively for authorized organizations in research, development, or manufacturing and are not intended for direct use by individuals or patients or as medical advice, diagnosis, or treatment.