Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.
The Coalition for Epidemic Preparedness Innovations (CEPI) is partnering with and funding a research project for Afrigen Biologics to investigate if the use of synthetic DNA can speed up mRNA vaccine development. The synthetic DNA will be manufactured and supplied by the CDMO Syngoi. The research project will develop a vaccine for Rift Valley fever, according to a Tuesday press release.
Bora Pharmaceuticals is gaining a 30.5% share in Tanvex Biopharma in a new partnership that will combine their manufacturing services. Bora will provide its 10 global manufacturing sites and Tanvex will provide its commercial facility in San Diego, CA. No financial details were given.
Bharat Biotech is launching an oral cholera vaccine, dubbed Hillchol, to address cholera vaccine shortages. The company will manufacture this out of its facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses, the company said on Tuesday.
John Kosolcharoen, CEO of two stem cell manufacturing companies, pleaded guilty on Monday for marketing products linked to patient hospitalizations. Since 2016, the two companies, called Liveyon LLC and Genetech Inc. have been making and shipping unapproved injectable stem cell products manufactured from human umbilical cord blood. Kosolcharoen lied to the FDA stating these were being sold for research purposes only, as per a DOJ press release on Tuesday.
AstraZeneca’s manufacturing facility in Södertälje, Sweden, has achieved a 98% reduction in greenhouse gas emissions since 2015, the company said on Thursday.
ScaleReady has awarded a $20 million grant to Stanford Medicine Laboratory for Cell and Gene Medicine to help the development of its CAR-T cell therapy manufacturing platform. The funding will be used to investigate the manufacturing tech in a Phase 1 clinical trial for Glypican 2 pediatric neuroblastoma and medulloblastoma, the company said on Tuesday.
Trinity Capital is investing $35 million into drug delivery device manufacturer ApiJect Systems. The funding will be used to expand ApiJect’s manufacturing footprint with a new facility, according to a press release on Tuesday.
Molecular Assemblies has received $4 million in funding from the Defense Advanced Research Projects Agency (DARPA) to further develop its DNA synthetic technology. The funding will be used for future tech transfers and to develop other software like gene synthesis, the company said on Wednesday.
Injectable CDMO Simtra Biopharma Solutions has tapped Lonza’s VP of Biologics, Lidia Serina, as its new head of development services. Prior to working at Lonza, Serina held positions at GSK, Sanofi and CureVac.
CDMO Huateng Pharma is expanding its services to include manufacturing pharmaceutical and veterinary APIs, chemicals and cosmetic ingredients, according to a press release on Wednesday.
Lupin Pharmaceuticals is voluntarily recalling 4554 bottles of its cefixime oral suspension from the US due to an out-of-specification result. The class 2 recall started on Aug. 21, according to a FDA report published on Monday.
Dr. Reddy’s Laboratories is also voluntarily recalling 103,298 bottles of 800 mg ibuprofen tablets after a specification study showed some levels of impurities. The bottles are being recalled from the US and Puerto Rico, and the process is ongoing. The FDA classified this as a class 2-level recall.