Oligonucleotide Therapeutics Analysis and Development Support Services
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.