Oligonucleotide Therapeutic Analysis and Development Support Services
Oligonucleotide therapeutic analytical development support services from initial characterisation and CMC to long term quality control.
Oligonucleotide therapeutics have been in clinical development for over 30 years initially with DNA-based therapeutics such as antisense oligonucleotides (ASOs) and aptamers, followed later with RNA-based therapeutics (e.g. siRNAs, mRNA, miRNA).
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 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 characterization 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 a heritage of supporting GMP manufacturing and regulatory submission requirements, our expertise supports your development from initial characterization and CMC through to long term quality control.