Development and Validation of Analytical Methods

Oligonucleotide drugs represent therapeutic molecules developed from nucleotide sequences that serve as key tools in gene therapy and RNAi applications alongside antisense oligonucleotides (ASO). Protheragen BioNucleics offers efficient and reliable analytical methods through its oligonucleotide drug CDMO services to assist with quality control and both process development and stability studies of oligonucleotide drugs.

Our Analytical Method Development and Validation Services

The class of therapeutic drugs known as oligonucleotide drugs finds frequent application in disease treatment through gene therapy, antiviral therapy and cancer treatment. The therapeutic effects of these drugs come from their ability to target precise nucleic acid sequences which leads to interference with gene expression or gene function modification. The unique structural features and physicochemical characteristics of oligonucleotide drugs create difficulties in developing and validating appropriate analytical methods. Protheragen BioNucleics offers essential services during the oligonucleotide drug development process.

Analytical Method Development

Develop methods for performing characterization and purity testing along with stability studies. Applicable to oligonucleotide drugs.

Analytical Method Validation

Check that the analytical method satisfies both ICH Q2 (R1) specifications and regulatory standards.

Quality Control (QC)

The quality control process involves backing GMP production to verify product quality matches specifications.

Process Development and Optimization

Data analysis provides essential support for enhancing both upstream synthesis and purification processes.

Analytical Method Development

When developing analytical methods for oligonucleotide drugs, factors such as sequence specificity, impurities, modification types, and stability need to be considered, which usually involve the following methods:

Structure and Sequence Confirmation

• High performance liquid chromatography-mass spectrometry (HPLC-MS)
• Mass spectrometry (MS, LC-MS, ESI-MS, MALDI-TOF-MS)

Purity and Impurity Analysis

• HPLC (IP-RP-HPLC / IEX-HPLC)
• Capillary electrophoresis (CE)
• PAGE

Content Determination

• Ultraviolet-visible spectrophotometry (UV-Vis)
• Quantitative fluorescence (qPCR)
• HPLC (IP-RP-HPLC)

Degradation Products and Stability Studies

• HPLC (RP-HPLC, IEX-HPLC)
• Mass spectrometry (LC-MS, MALDI-TOF-MS)

Biological Activity

• Cell experiments (qPCR, ELISA, Western Blot)
• In vitro transcription and translation experiments

Advantages of Our Analytical Method Development and Validation Services

• Professional Technical Team: The scientific team at Protheragen BioNucleics specializes in oligonucleotide development and analysis while offering expert technical support.
• Customized Services: The company modifies analytical methods to fit customer needs which enables the delivery of precise results that fulfill various project requirements.
• Latest Technology Platform: Protheragen BioNucleics utilizes state-of-the-art technology and instruments to perform detection with high sensitivity and resolution which delivers robust data to support drug development.
• Comprehensive Analytical Solutions: Through its one-stop analytical solutions Protheragen BioNucleics aids customers in saving time and resources during drug development from quality control to stability studies.

Validation of Analytical Methods for Oligonucleotide Drugs

Method validation aims to verify that newly developed analytical methods perform reliably throughout their intended application range. Analytical methods validation stands as an essential process to guarantee the quality and safety of oligonucleotide drugs. The validation process for analytical methods includes several key aspects.

Appropriate statistical methods and tools must be utilized for data analysis during each aspect's validation process to produce scientific and credible results. The validation experimental design and selected standards and equipment will differ depending on specific conditions. will vary according to actual conditions.

Protheragen BioNucleics builds strong customer relationships by implementing cutting-edge analytical methods and instruments that deliver efficient technical support for drug research projects. Our researchers deliver satisfactory assistance for quality control as well as process development and laboratory testing requirements. Should you require support, contact us to unlock the full potential of your research and therapeutic endeavors.

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.