Through this partnership, contract development and manufacturing organization (CDMO) Batavia Biosciences will increase its recombinant adeno-associated virus (rAAV) production capacity while reducing manufacturing costs. The partnership will focus on development and integration of Batavia’s rAAV manufacturing platform HIP-Vax and ChromaTan’s BioRMB technology.
This partnership has also won the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) grant and financial assistance from the US Department of Commerce, National Institute of Standards and Technology.
“We encountered each other at the previous NIIMBL National Meeting and, while having a drink, reasoned that an integration of their technologies could offer a nice innovation for the community,” a spokesperson for Batavia told BioProcess Insider.
“The proposed integration of technologies will be developed as a scale-able and versatile manufacturing platform, thus enabling the production of rAAV vectors of different serotypes at sufficient quantities targeting the repair of various genetic disorders.”
Based on the increasing demand for rAAV vectors for gene therapy applications, drug developers are seeking large scale manufacturing capacity to produce clinical trial materials. However, according to the firm, such large-scale manufacturing facilities are scarce as they require major investments, creating a bottleneck for further growth in clinical trials for rAAV-based gene therapies.
Meanwhile, “chromatography has previously been shown to intensify and reduce the costs of manufacturing processes for monoclonal antibodies while achieving comparable or improved purities. Yet, similar applications for rAAV are currently still lacking,” the spokesperson said.
And: “Continuous production processes are one of the most effective methods for performing biotechnological process intensification to improve product quality, reduce the footprint needed for manufacturing, and improve efficiency by greatly reducing process times for ramp-up and ramp-down.”
Apart from Batavia and ChromaTan, NIIMBL awarded $10 million to eight projects in total. However, the financials associated with this partnership have not been disclosed.
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