Oligonucleotide therapeutics analytical development support services from the initial characterisation and CMC through to long term quality control.

Analysis and development of oligonucleotide therapies such as antisense oligonucleotides (ASOs) and aptamers, or RNA-based therapeutics (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 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 from the inception of the therapeutic class. 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 therapeutics and 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.

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Oligonucleotide Characterisation 
Confirm identity, determine safety, efficacy, purity, quality, and strength and identify and quantify contaminants
mRNA Characterisation and Analysis
Supporting therapeutic and vaccine development to assess clinical translation efficiency and immunogenicity
 Brochure: mRNA Characterisation Services
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Delivery Technologies
Physico-chemical characterisation and release testing services for nanoparticlesviral vectorsliposomes and lipid nano-particles
Spotlight-Bioanalysis
Bioanalytical and Biomarker Services 
Immunochemistry and biomarker services for bioanalytical studies supporting preclinical and clinical development
extractables-and-leachables

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

Potency
Potency Testing
Customised cGMP cell-based potency assays to quantify the biological activity of oligonucleotides
Spotlight-StabilityStorage
Stability Testing & Storage
GMP stability studies and ICH storage services supporting development, batch release and quality control testing
Spotlight-Inhaled-Nasal Drug-Development
Inhaled or Nasal Drug Development
Development services including formulation development, GMP testing and clinical trial material manufacturing
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Intertek Pharmaceutical Services Manchester
P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom

For location use: M9 8GQ

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