Manufacturing roundup: Catalent caps off manufacturing site in Belgium; EuroAPI restarts production in Hungary

02 Feb 2023
endpts.com
Phase 1Orphan DrugExecutive Change
Catalent is opening the doors to a new plasmid DNA manufacturing site at one of its core sites in Europe. The new 12,000-square-foot plasmid manufacturing site is located in its cell therapy center in Gosselies, Belgium, and has multiple cleanrooms meant to produce cGMP-grade plasmid DNA for clinical and commercial purposes. The site will also see Catalent producing plasmids that are intended to be used by cell and gene companies. “Plasmid DNA is a critical component to many biological therapeutics, and Catalent has made this investment in additional manufacturing capacity in anticipation of supporting the growing number of programs through development towards commercialization,” said Manja Boerman, Catalent’s president for biomodalities, in a release. The Sanofi spinoff EuroAPI has restarted the manufacturing of prostaglandin at its site in Budapest, Hungary. In December, EuroAPI said in a release that it had discovered GMP shortfalls related to documents during an internal assessment and decided to suspend the manufacturing of prostaglandin at its Budapest site. Since then, EuroAPI said that it has put in a plan to make corrections which allowed the manufacturer to restart production in January. EuroAPI stated that it expects the bulk of prostaglandin production to be back online by the middle of April. EuroAPI also stated that no other activities at the site were impacted by the suspension. Carbogen Amcis has opened a new site for manufacturing injectable drugs has opened in Saint-Beauzire, France. The new manufacturing site, which is not from an existing Carbogen Amcis facility, plans to boost the development and production of liquid and freeze-dried products that are for clinical trials and small-scale commercial activity. Construction on the 9,500 square meters facility itself started in January of 2021 and has two production lines. The site will have a headcount of around 100, with Carbogen Amcis planning to create 50 jobs throughout the year. “Over the last six years, CARBOGEN AMCIS has continued to expand our facilities and grow our capacity, enabling us to support more customers and increase access to new and diverse technologies and services,” said CEO Pascal Villemagne in a release emailed to Endpoints News. Pasithea Therapeutics inks deal with WuXi STA to manufacture ingredient for its candidate The Florida-based biotech Pasithea Therapeutics has netted a manufacturing contract with WuXi STA for the CDMO to produce the active pharmaceutical ingredient (API) for its MEK inhibitorMEK inhibitor dubbed PAS-004. Pasithea said in a release that it plans to submit an IND to the FDA sometime in the latter half of this year and is getting the materials to make progress on the drug. “WuXi STA has a proven track record of manufacturing success to FDA standards, and we believe that their high-quality capabilities will support the progression of our drug candidate into the clinic. PAS-004 has already received orphan drug designation from the FDA for neurofibromatosis 1, and we plan to start our phase 1 clinical trial in the second half of 2023,” stated Graeme Currie, chief development officer of Pasithea, in a statement . The active pharmaceutical ingredient manufacturer Seqens Group has opened the doors to a new 15,000-square-foot R&D center in the Boston suburb of Devens, MA. According to Seqens, it placed a $5 million investment into the facility and will replace a smaller facility it has in Devens. The manufacturer also plans to double the headcount of scientists at the location by 2026. The site plans to boost the development of APIs and other materials, such as lipids that are used in RNA vaccines. The site will also serve as a major piece of its R&D network, which Seqens has a total of 10 across North America and Europe. Seqens also has a manufacturing facility in Newburyport, MA. “Everything starts with R&D. Transitioning our R&D center of excellence to the new Devens facility is an opportunity to continue our expansion into the U.S. market, within a state known as a vibrant academic hub, and support our customers with integrated R&D services that set new benchmarks for innovation, safety, sustainability and quality,” said Pierre Luzeau, president and CEO of Seqens Group, in a release . The Genetic medicine biotech ReCode Therapeutics has brought on a new SVP of quality and chemical, manufacturing and controls (CMC) regulatory affairs. April Loui has been brought on to oversee the regulatory strategies for CMC and quality for the company. Loui has over 25 years of experience in the biotech and pharma world. Recently she served as CEO and founder of Clarity Global, which consulted life sciences companies on best practices for the development of commercial operations and guiding clients through compliance with health authorities. Loui also served as the VP of quality at Alector and, before that, was the senior director of CMC clinical quality operation at Gilead Sciences. She also served as the head of quality at Avid Bioservices.
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