ReciBioPharm (previously Arranta Bio) has partnered with MIT to develop a continuous manufacturing technology for mRNA therapeutics.
The three-year deal is part of the US Food and Drugs Administration’s (FDA’s) initiative to create a fully integrated, continuous production line for messenger RNA (mRNA) vaccines, which will support future pandemic threats.
The project aims to advance mRNA therapeutics to patients globally, not just for rapid response against future pandemic threat. The deal will also research mRNA therapeutics to treat rare diseases, cancers, and infectious viruses (influenza and Zika).
“We have developed a robust mRNA batch production process that offers high yields and exceptional purities to nucleic acids customers,” a spokesperson for Recipharm told BioProcess Insider.
“This new technology will leverage our current mRNA platform and apply it to innovative flexible technologies in continuous processing. This will unlock the potential of high-quality mRNA therapeutics capable of being deployed around the world in a diverse set of environments. The technology is intended to be adaptable to small footprints, while producing significant mRNA quantities through a continuous system.”
Continuous manufacturing (CM) whether by perfusion in the upstream or downstream has become a hot topic as it means you do not require as many staff or equipment as it works by constantly producing cells and drugs. The US Food and Drug Administration (FDA) published its final CM guidance in March entitled Continuous Manufacturing of Drug Substances and Drug Products.
The guidance aims to help industry develop, implement, and operate lifecycle management processes for CM. Much of the guidance focuses on small molecule chemical entities but the document also offers large molecule makers guidance.
According to both parties, the project aims to tackle the challenges associated with continuous manufacturing and the FDA will provide direct support and inform the advances to enable ReciBioPharm and MIT to go beyond the current production testing practices.
“mRNA is a critical modality for rapid development and delivery of new therapeutics and vaccines, with exceptional safety profiles and flexible platforming options. The ability to screen hundreds or thousands of candidates quickly and insert them into a robust cGMP manufacturing platform means that the barriers to new medicines are significantly lower than previous modalities,” the spokesperson said.
The work will take place at ReciBioPharm’s facility in Watertown, Massachusetts. In March, Recipharm expanded the RNA process development capacity by 50% through a 2,000 square-foot buildout at the plant.