Cell and viral vector backlogs reduce patient access to next-generation medicines and slow R&D says the consortium behind a $50 million innovation hub.
The group, led by Harvard University, made the comments this week, explaining that while some contract development and manufacturing organizations (CDMOs) offer cell line and vector services, growing demand means developers can face delays.
“Manufacturing backlogs are slowing the production of cells that are essential to research, holding up the availability of new treatments headed for the clinic.”
The consortium – which also includes MIT, Fujifilm Diosynth Biotechnologies and GE Healthcare – announced plans to set up a manufacturing center in the Boston metro area.
The facility is designed to foster development of production methods for cell and gene therapies, biologics and immunotherapies.
It will house eight cleanrooms for the production of cell and viral vector products and other related raw materials that may be used for phase I or phase II clinical trials.
The plan is to kit the site out with modular technology according to the consortium, which said flexibility is key to helping developers move from lab to the clinic.
“The modular design of the new facility will make it easier for users to adapt quickly to changes in technology.
“Such flexibility will remove barriers to accessing promising innovations that emerge from improved methods involving gene manipulation, gene editing, oligonucleotides, peptides, and new methods and discoveries as they arise.”
The facility will also provide hospitals with capacity to make customized patient-specific batches of therapeutics.
Better manufacturing techs are vital if next generation medicines are to fulfill their potential according to Emmanuel Ligner, CEO of consortium member GE Healthcare Life Sciences.
“While these therapies are promising, challenges in manufacturing, access and cost must be addressed so they can reach their full potential.
“Initiatives such as the center are important because they bring together key life sciences stakeholders together to share their capabilities, knowledge and expertise to collaborate and accelerate innovation.”
This was echoed by Martin Meeson, president of Fujifilm Diosynth Biotechnologies, US. He said the CDMO’s participation would bring “expertise and capacity to the one of the leading biotechnology ecosystems in the world.”
Specifics of how companies can use the facility were not disclosed, although the consortium said it will provide access “at favorable pricing, reducing the wait and cost for researchers at universities, hospitals and start-ups.”