Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more.
Asymchem Laboratories will take over operations at Pfizer’s API facility in Sandwich, UK, which the pharma company previously said it would downsize. The facility is Asymchem’s first site in Europe and will be used for small molecule clinical development. Manufacturing will be operational in June, and future additions will include manufacturing peptides and oligonucleotides. Around 100 workers will be employed at the site, including some previous Pfizer staffers, according to a release Tuesday.
Serum Institute of India has shipped malaria vaccines, co-developed by the University of Oxford and Novavax, to Africa. Around 43,200 doses of the vaccine, dubbed R21/Matrix-M, were shipped on Monday. Overall, 1.6 million doses will be shipped, according to a Monday release.
The FDA handed Laurus Synthesis an untitled letter after an inspection in Parawada, India, found issues in the company’s API manufacturing. The agency said Laurus failed to investigate abnormal water system monitoring results and that it did not properly clean equipment, according to the letter published on the FDA website Thursday.
Chemical maker Seatex received a warning letter from the FDA because it manufactured “over-the-counter hand sanitizer drug products” with the same equipment used to make floor cleaner, according to the letter published Tuesday. Further, the company did not properly test components, such as ethanol and glycerin, to be used in drug products. The warning letter was sent after an inspection in Rosenberg, TX.
An unnamed pharma company will license DelSiTech’s technology to develop an unnamed injectable drug product. DelSiTech will receive $9 million upfront with the potential of $200 million in milestone payments, according to a Thursday release.
Life science tools company Limula has raised $6.8 million in seed funding to support its automated cell therapy manufacturing platform. LifeX Ventures led the raise with participation from other investors such as Verve Ventures, Zühlke Ventures and Oxford Seed Fund, the company said Tuesday.
CDMO Scorpius — formerly NightHawk Biosciences — opened a new storage and testing site in San Antonio, TX. The new facility will store raw materials and bulk drug substances, and will also be used for sampling and quality control testing, Scorpius said Monday.
Astellas Pharma signed a memorandum of understanding with Yaskawa Electric so they can work on building a platform for cell therapy development and manufacturing, according to a Tuesday release.
Cell and gene therapy manufacturer Xcell Biosciences and CDMO AmplifyBio announced on Monday they are partnering to improve manufacturing of engineered T cell receptor therapies for solid tumors.