Manufacturing roundup: Catalent to produce low-cost version of naloxone; CSL opens R&D site

2023-03-30

疫苗细胞疗法上市批准优先审批

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics. Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed. Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024. “This agreement marks a major milestone for Harm Reduction Therapeutics and is also a significant step forward in tackling a major public health issue in this country,” said Carla Vozone, VP of inhalation strategy at Catalent, in a release . CSL is opening a new 140,000-square-foot R&D center in Waltham, MA. The new site will include 54,000 square feet of lab space and will serve as the hub for CSL’s current and future vaccine design. CSL already has several locations across the US as well as Australia, Germany, the Netherlands and Switzerland. An Indian-based manufacturer of cough syrup, Marion Biotech which had allegedly led to deaths in Uzbekistan, had its license revoked by the local government. According to a report from the BBC, authorities in the Indian state of Uttar Pradesh canceled the license of Marion Biotech, stopping it from further manufacturing activities. In January, the WHO, along with the Uzbekistan Ministry of Health, issued an alert for several batches of cough syrups made by Marion after having found levels of diethylene glycol or ethylene glycol in them. The US branch of the Chinese CDMO PharmaBlock has opened a new R&D facility in the Philadelphia suburb of West Chester, PA. The new 30,000-square-foot facility includes research labs, clean rooms, manufacturing suites and analytical labs. The CDMO is also planning to manufacture active pharmaceutical ingredients in West Chester by 2024. “This state-of-the-art facility will enable us to provide our clients with the highest quality research and development solutions, and we look forward to continuing to innovate and advance,” said Jing Li, president of PharmaBlock (USA), in a release . PharmaBlock entered the US market in 2012 with a sales office in the Bay Area and eventually established an R&D facility in Hatfield, PA. Thermo Fisher and biotech Arsenal Biosciences will be entering into a collaboration to develop and produce autologous T cells for cancer treatment. Arsenal recently advanced its lead candidate, a T cell therapy for ovarian cancer, into clinical manufacturing and is working with Thermo Fisher’s line of products for cell therapy production. However, no other details on the partnership were disclosed. Thermo Fisher and Arsenal began working together in 2020. The Canadian specialty pharma outfit Juno Pharmaceuticals has received approval from Health Canada to import eptifibatide solution and has secured a six-month supply. According to a company release, the drug is used for patients with types of acute coronary symptoms to help prevent blood clots. This is used when patients undergo interventions, including stenting. However, the drug has been in limited supply since October 2022. Juno is centered on sourcing and importing medications that are having shortages in Canada and bringing them in. “Preventing future shortages will require encouraging global players to bring their products to the Canadian market. As we look to the future, investing in domestic production and bolstering bricks and mortar manufacturing on Canadian soil should be a priority,” said Juno CEO Mark Mantel in a release .

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