Oligonucleotide Analysis

Oligonucleotide analysis and development of oligonucleotide therapeutics such as antisense oligonucleotides (ASOs) and aptamers, or RNA-based medicines (e.g. siRNAs, mRNA, miRNA) involve a strategic approach to formulation and analytical development. The method of production can impact purity as well as the secondary structure – which in turn can impact stability and solubility.

The structural properties of these products present many challenges in both synthesis and analysis. With a growing oligonucleotide drug development pipeline, the safety, efficacy, purity, stability, and activity of these products are a concern for developers – particularly in the absence of specific, dedicated regulatory guidance.

Intertek Pharmaceutical Services has supported oligonucleotide drug development since the therapeutics class’s inception (30 years). Our analytical scientists support product development, from quality control testing of amidite starting materials and early-stage product characterisation through to GMP batch release testing for either single strand or duplex products. We conduct integrated stability programs for oligonucleotides incorporating ICH storage and testing to cGMP. We have specialist expertise in inhalation drug product development, and extractable and leachables studies and our bioanalysis experts design and manage strategic work programs to support your preclinical and clinical development. 

With experience in the strategic application of orthogonal analytical techniques for oligonucleotide analysis and a heritage of supporting GMP manufacturing and regulatory submission requirements, our expertise supports your development from initial characterisation and CMC through to long-term quality control.

Oligonucleotide Characterisation 

Confirm your oligonucleotide therapies identity, determine safety, efficacy, purity, quality, and strength and identify and quantify contaminants

mRNA Characterisation and Analysis

Supporting mRNA therapeutic and vaccine development to assess clinical translation efficiency and immunogenicity. Brochure: mRNA Characterisation Services

Delivery Technologies

Physico-chemical characterisation and release testing services for nanoparticles, viral vectors, liposomes and lipid nano-particles

Bioanalytical and Biomarker Services 

Immunochemistry and biomarker services for bioanalytical studies supporting preclinical and clinical development

Extractables & Leachables Studies

Assess and quantify risk associated with potential leachable impurities from container closures, process equipment or packaging

Potency Testing

Customised cGMP cell-based potency assays to quantify the biological activity of oligonucleotides

Stability Testing & Storage

GMP stability studies and ICH storage services supporting development, batch release and quality control testing

Inhalation Drug Development

Inhaled or nasal drug development services including formulation development, GMP testing and clinical trial material manufacturing

WEBINAR: Designing a QC Strategy for mRNA Vaccines

CASE STUDY: CMC Considerations for mRNA Based Therapies  

SPECIAL REPORT: Analytical Challenges - Characterisation of Oligonucleotide Therapeutics

PRESENTATION: Data Analysis for CMC Testing of Oligonucleotides

CASE STUDY: Determination of Melting Temperature for Oligonucleotide Duplexes using NMR

CASE STUDY: Identification Testing by Accurate Mass and MS/MS Sequencing

ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies

CASE STUDY: CMC Considerations for mRNA Based Therapies

 

COVID-19 VACCINE OR THERAPEUTIC TESTING & DEVELOPMENT SUPPORT

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ARTICLE: Repurposing Vaccines for Intranasal Development 
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WEBINAR: Repurposing Drugs for Inhaled Delivery 
eBOOK: Contingency Outsourcing Solutions

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