As part of the collaboration, Curia said its experienced process development team will support the GMP production of Replicate Bioscience’s srRNA vectors up to eight-liter scale that can be used in Phase 1 through pivotal clinical trials.

The CDMO’s ISO-13485 certified globally oriented US mRNA development and manufacturing facility near Boston, Massachusetts, also supports innovators engaged in vaccine and other mRNA therapy development and manufacture through Phase 2 and 3, including GMP assays, Curia said. Other of its facilities support manufacture of srRNA through commercial production scales.

Replicate’s co-founder and chief development officer Andrew Geal, who previously has set up srRNA CMC frameworks for companies including Novartis, Synthetic Genomics and Precision Nanosystems, said customization has important therapeutic advantages, including versatility of application, lower dosing and longer duration of therapeutic effect compared to other RNA modalities, but requires built-for-purpose processes to solve the challenges of manufacturing longer RNAs.

Curia’s expertise in process development and end-to-end integration of longer RNAs s will aid the company as it transitions from research into clinical development and the production of our srRNA for trials in patients, Geal said.

For Curia, Norman Garceau, vice president, Global R&D Technology, said the collaboration will enable the company to create entirely new methods of manufacturing longer RNAs. He added that the manufacture is more technically challenging than for non-replicating mRNAs. To date, the CDMO has succeeded with mRNAs up to 16,000 bases.

Author: Dede Williams, Freelance Journalist