Catalent, Nanoscope Therapeutics expand gene therapy agreement

The expanded collaboration adds commercial-compliant packaging and distribution for MCO-010, an optogenetic gene therapy targeting retinal degenerative diseases.

Catalent, a global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida, has expanded its partnership with Nanoscope Therapeutics, a Dallas-based biotechnology company, to support late-phase clinical and commercial supply of MCO-010, an optogenetic gene therapy being developed to restore vision in patients with advanced retinal degenerative diseases including retinitis pigmentosa and Stargardt disease.

Under the expanded agreement, Catalent will provide commercial-compliant packaging and distribution for MCO-010 and has secured a commercial packaging validation program to support Nanoscope’s Biologics License Application with the FDA, according to the announcement. A rolling BLA submission is currently underway, the company said.

MCO-010 is designed to reprogram retinal cells to become light-sensitive, targeting patients with late-stage disease who currently have limited therapeutic options, according to the announcement.

Sulagna Bhattacharya, CEO of Nanoscope Therapeutics, said in a statement that having a packaging partner able to scale to meet the needs of global commercialization is essential as the company continues to manufacture MCO-010 commercial drug product.

The announcement follows two recent developments at Catalent. Earlier this week, the company agreed to sell its Nottingham, UK facility to Codis, a CDMO specializing in spray drying and particle engineering, as part of Codis’ expansion of its integrated oral solid dose and spray drying network in Europe. In June, Catalent launched its first enterprise AI tool to accelerate root cause analysis and corrective action development for quality management processes across its manufacturing network.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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