Coriolis Pharma launches U.S. entity alongside innovative drug product platform service offerings for monoclonal antibodies

Coriolis Pharma announces the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise. In parallel Coriolis introduces two novel platform services for developability assessment and pre-formulation screening.

Coriolis Pharma launches U.S. entity alongside innovative drug product platform service offerings for monoclonal antibodies

• New entity offers U.S. partners the convenience of local presence with the advantages of international expertise
• Novel developability assessment and pre-formulation platform services shorten time-to-market and de-risk drug product development projects

Martinsried-Munich, Germany, May 29, 2024 – Coriolis Pharma, a globally operating service provider for R&D and GMP drug product development, R&D and GMP analytics and sterile drug product manufacturing support, announced the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise. U.S. customers will be served by the U.S.-based Coriolis commercial organization, which consists of business development and client project management professionals.

Coriolis is also launching two novel platform services for developability assessment and pre-formulation screening, designed to de-risk and accelerate the path of antibody drug candidates to the clinic. The new platform services are streamlined encapsulations of   Coriolis’ scientific experience with over 1,500 successful biologics development projects in all stages of development, including commercial products.

The new U.S. entity and platform services offer Coriolis clients more convenience and faster access to the company’s scientific expertise, ensuring the long-term success of drug product development projects.

“Because the U.S. will remain the center of innovation for biopharmaceuticals and cell and gene therapies, we believe it is critical to provide in-market project management, business development, and logistical support to our U.S. clients,” said Coriolis CEO Silvia Steyrer-Gruber. “The establishment of our U.S. entity opens the next chapter in expanding the global footprint of Coriolis.”

Coriolis’ science-based developability assessment platform for antibodies enables the selection of candidates with optimal biophysical properties for successful drug product development, scale-up, and market launch. This service package is highly beneficial for projects with low material availability (in the single-digit mg space) per antibody candidate. Projects can start immediately with innovative pricing models that appeal to small biotech start-ups and Big Pharma companies alike.

Meanwhile, Coriolis’ new systemic antibody pre-formulation platform generates a comprehensive data set for holistic drug product development by systemically screening a vast antibody-relevant formulation space of excipients from FDA-approved drugs. Readouts from predictive methods, as well as assessment of critical Quality Attributes (cQA) through accelerated stress testing, facilitate the selection of the best lead formulations for subsequent stability studies and further pre-clinical development. The service package mitigates risk by ensuring that an antibody can be developed into a commercial product in line with the clients’ Quality Target Product Profile (QTPP) with a stable formulation right from the start.

“Coriolis’ new science-driven developability assessment and pre-formulation screening offering signify the launch of a comprehensive program aimed at delivering advanced client-focused services,” said Coriolis CCO Johannes Clemens. “Engaging with Coriolis during the discovery and pre-clinical stages enable clients to accelerate time to market, reduce development risks, and proactively manage drug product development, ultimately increasing the valuation for licensing and M&A deals.”