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Notes on compliance: USP 60 compliance doesn’t have to be complicated
07-Jun-2021 Last updated on
The regulation, which was triggered by a string of
Burkholderia cepacia complex (Bcc) infections linked to non-sterile aqueous products, means laboratories are having to build new processes from the ground up.
It is not easy, but compliance does not have to be complicated. Validated microbial limit databases and simple tweaks to common workflows will ensure your products remain Bcc free and USP 60 compliant.
New BD plant set for Spain aims to meet growing demand for PFS Becton, Dickinson and Company (BD) is to build a new plant in Zaragoza, Spain, with an investment of €165m (US$200m). The site will produce glass pre-filled syringes and plastic components.
“BD s new plant in Zaragoza will produce drug delivery devices, primarily for pharmaceutical companies that supply the European market with drugs in PFS such as vaccines and other biologics,” said Eric Borin, worldwide president of BD Pharmaceutical Systems.
In December, the medical technology company and pioneer of the prefilled syringe (BFS), announced plans to invest around US$1.2bn over a four-year period to expand and upgrade manufacturing capacity and technology for PFS, as well as advancing drug delivery systems (ADDS) across its six global manufacturing locations. It mentioned then that spend would include the addition of a new site in Europe, with the announcement this week of the Spanis
Sanofi and GSK announced today that their COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase 2 trial.
The investigational COVID-19 vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines, along with GSK’s established pandemic adjuvant technology.
The drug companies had hoped to have regulatory approval for their jab in the first half of this year, but interim results from a Phase 1/2 study, released in December 2020, had shown an
“insufficient” response in the over-50s, the age group deemed at higher risk for contracting the severe form of the virus.
Novasep expands in France, sees increasing customer demand for ADC manufacturing services Novasep has announced a further expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities at its Le Mans, France site, saying the move strengthens its position as a leading CDMO for the production of innovative and targeted molecules to treat cancer.
The Le Mans site has already benefitted from significant investment.
Now, to support further growth and to sustain the increase in both clinical and commercial production capacity at the facility, the contract development and manufacturing organization (CDMO) is investing more than €4m (US4.84m) in the site, with it also set to boost employees numbers there; over 30 new hires are planned.