Roslin Cells has signed a contract with Neusentis, a research unit of Pfizer based in Cambridge, UK, to support the manufacture of retinal pigment epithelium (RPE) cells to be used in a cell therapy clinical trial.
As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.
Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.
Enzyme experts trying to make the anticancer APIs vincristine and vinblastine with engineered cell lines say the technology could be used to produce a wide range of plant-derived drug actives including alkaloids like morphine.
Cell transportation technology firm Austrianova has licensed a low-cost, disposable microfluidics platform from SIMTech to improve how it dispenses cells used in biomanufacturing and therapeutic applications.
Scientists at the University of Nottingham have created a new combination of hydrogels that allows dense tissue structures to be produced from human pluripotent stem cells (HPSC) in a single step process never achieved before.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
After making significant investments in its personalized immunocellullar manufacturing technology, Prima BioMed is looking to scale up the platform as the company’s lead product enters Phase II trials.
Catalent Pharma Solutions has agreed with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.
Biopharma desire to speed up the extraction and freezing process necessary for the safe transport of cell-based regenerative medicines is driving demand for cryopreservation reagents, according to biologics CDMOs.
CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections.
Scientists at Caltech have published a study in Nature Medicine this week demonstrating that a gene therapy technique that boosts a mouse’s protection against HIV also works against HIV that’s transmitted via mucosal surfaces.