EUROAPI is a CDMO player with specialisations across many molecules including oligonucleotides. The company operates along two main business lines, CDMO activity and the API catalogue. In keeping with a sustainable business model, EUROAPI has demonstrated commitment to the ISO 5001 and ISO 14001 standards and purchase around 80% of their electricity from renewable sources.
Thorsten Naumann, Head of R&D Germany and TIDES platform at EUROAPI, introduced their TIDES platform. The oligonucleotide team has over 20 years of experience running clinical and industrial-scale activities; the first installation of solid-phase equipment took place in 2004. Furthermore, EUROAPI collaborated on a pioneering ASO (antisense oligonucleotide) project to launch MIPOMERSEN in 2014. Naumann stressed that the oligonucleotide team's expertise and cutting-edge equipment allow them to reach full capability from the development scales through the clinical phases towards the commercial scale.
Regarding the equipment, EUROAPI has an OP10 with a small milligram scale, an OP100, and OligoSynth which is used for scaling tox studies into first GMP scaling. Naumann also highlighted plans to install an AK biosystem for further GMP scale-up. For downstream processing, chromatography is the main method. Currently, two chromatography systems (450mm diameter) handle both oligonucleotides and peptides, with a third (800mm column dedicated to oligonucleotides) being installed for large-scale purification (up to 3 kg per batch). Naumann also emphasised the importance of consistency, so they ensure the same oligonucleotide team is dedicated to the downstream processing and upstream processing.
Moreover, the company has expertise in method development, validation, regulatory dossier preparation, and direct interactions with EMA and FDA. Therefore, EUROAPI can assist their clients with regulatory compliance. EUROAPI is well versed in raw material classification and measurements and support their customers during intermediates processing, process monitoring, and final drug substance release.
Naumann stated that: “Innovation is still at the heart of the R&D team.” To show commitment to this ethos, the team are working to monitor solvent consumption, waste generation, optimisation of oligonucleotides. EUROAPI is working with PeptiSystems to optimise solid phase synthesis and flow rate. Due to discussions around banning DMF, Naumann mentioned that EUROAPI is pursuing cleaner technologies to promote greener synthesis.
Adopting a customer centric approach is essential for EUROAPI, customers benefit from end-to-end support, high-quality and reliable services and strong compliance and quality standards. Naumann showcased the impressive oligonucleotide services which well-position EUROAPI to support the growing demand for oligonucleotide therapeutics.
