Aurisco Pharmaceutical, a leading global Oligonucleotide and Peptide (TIDES) manufacturer, is leading the generic wave on these new modalities after becoming the first and only generic Oligonucleotide API manufacturer to be USFDA approved.
A new era in oligonucleotides
Aurisco’s USFDA’s inspection marks more than a corporate milestone; it signals a new era for oligonucleotides. FDA had approved 24 oligonucleotide medicines, including 12 ASOs and 8 siRNAs, yet no generic oligonucleotide had been approved in the US. However, Paragraph IV competition is intensifying: Leqvio (inclisiran) has one ANDA filed, alongside two Spinraza (nusinersen) ANDAs and one Amvuttra (vutrisiran) ANDA. Generic oligonucleotides are moving closer to US patients.
To help generic companies develop safe and affordable versions of these medicines, USFDA has published 18 product-specific (draft) guidances (PSGs) for generic oligonucleotide drug products with 2 additional planned for February 2027. In addition, pre-ANDA meetings are available and fundamental to ensure the regulatory strategy is adequate and data provided by the API manufacturer is sufficient. Aurisco has been actively supporting customers in interacting with USFDA, EMA and other Agencies. To demonstrate Q1/Q2 formulation sameness and API sameness, the ANDA holder and API manufacturer should be able to provide comprehensive method validation data to demonstrate the adequacy of the selected methods. The demonstration of resolution of the analytical methods and comparative impurity profiling of an ASO or a siRNA requires the synthesis and characterization of 50 to 100 potential process impurities. Behind every oligonucleotide DMF there is a ton of analytical work.
The growing knowledge of disease mechanisms is expanding the potential of oligonucleotides into larger cardiovascular, degenerative and metabolic indications – Inclisiran and vutrisiran illustrate this shift toward substantially larger patient populations. Larger patient populations will require greater manufacturing capacity, lower costs, and more sustainable production technologies. To address this, Aurisco is combining chemical synthesis with enzymatic ligation, developing intelligent design and directed evolution methods for non-natural nucleic acid ligases. Its scientists use AI-assisted enzyme design to enable recognition and ligation of modified phosphorothioate-containing substrates, while optimizing ligase expression and production at high substrate concentrations. These capabilities will support efficient manufacturing of increasingly long, modified, and structurally complex therapeutic oligonucleotides at commercially scale while improving product consistency and reducing environmental burdens across the entire lifecycle.
cGMP Oligonucleotide API Manufacturing at Aurisco.
About Aurisco
Aurisco Pharmaceutical Co., Ltd. (SSE: 605116) serves global markets since 1998. With 6 R&D centers, 4 manufacturing sites and sales offices in USA, Portugal, India and Brazil, the company focuses on complex products. With 100+ patents filled worldwide and 300 scientists, the company offers an IP safe and a cGMP and ESG compliant environment for NCEs and complex generics.
Being Ecovadis Gold ranked, Aurisco has joined the SBTi, M2030 and the SPP. Aurisco passed RX360 supply chain security inspection and has been audited by the Pharmaceutical Supply Chain Initiative (PSCI).
For further information, please visit www.aurisco.com and follow us on LinkedIn or contact info@aurisco.com.
