Catalent welcomed the news from Nocion Therapeutics that its first patient has been dosed with NOC-100, an inhaled formula of its NTX-1175 small molecule candidate.
NTX-1175 is being developed to treat cough and has received priority review through the U.K.’s Medicines and Healthcare products Regulatory Agency, as NOC-100 has the potential to treat both chronic and acute cough – the latter a common symptom in patients with COVID-19 and associated with transmission of the SARS-CoV-2 virus.
To support this program, Catalent rapidly developed and manufactured clinical-scale batches of blow-fill-seal (BFS) nebulizer ampules at its Woodstock, Illinois facility, a process it was able to accelerate from program inquiry to clinical supply in less than six months.
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“Blow-fill-seal technology offers many advantages for aseptic manufacturing. This proven platform has a low risk profile, and was ideal to accelerate development and production to meet the time frame of this project,” said Jonathan Arnold, President, Oral and Specialty Delivery at Catalent. “Our deep expertise in complex BFS formulation and fully integrated services allowed us to respond very quickly to the needs of this new and important clinical trial that also has the potential to make a positive impact on COVID-19 patients.”
Catalent’s 430,000 square-foot facility in Woodstock is the company’s center of excellence for sterile liquid fill/finish, leveraging advanced aseptic BFS manufacturing technology. The site has over 35 years’ experience in providing BFS solutions for the most complex emulsions, suspensions and biologics, and houses over 30 BFS filling suites, as well as dedicated scale-up machinery, providing flexible capacity and services from early clinical stages through commercial production for ophthalmic, respiratory, topical, and biologic markets.