Page 7 - Upstream Processing News Today

Biogen on aducanumab: ‘We’re ready for an immediate launch’ Biogen expects to begin shipping Aduhelm (aducanumab-avwa) in two weeks: after the FDA granted the Alzheimers drug accelerated approval on Monday. There are around 900 sites across the US ready to implement treatment, including clinical trial centers and others with the necessary infrastructure to diagnose and treat patients. Initial supply will come from Biogen’s Research Triangle Park (RTP) in No...

Raw materials play a vital role in the development of cell and gene (CGT) therapies.

What are some of dos and don’ts on starter materials for CGT manufacturing? Raw materials play a vital role in the development of cell and gene (CGT) therapies. Mike Brewer, director, global principal consultant, regulatory, bioproduction, Thermo Fisher Scientific, spoke to BioPharma-Reporter about some of dos and don’ts on starter materials for CGT manufacturing. His advice is particularly targeted at newer entrants to the CGT space, those at the at the preclin...

Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.

Sanofi and GSK have started the Phase 3 study for their COVID-19 vaccine candidate: eying up potential regulatory authorization in Q4, 2021.

Univercells and NIBRT partnership looks to plug gaps in CGT manufacturing skillset Univercells Technologies’ scale-x carbo bioreactor is to be used at the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. The biomanufacturing technology provider and the Irish facility said that the rapid growth of cell and gene therapies (CGTs) together with the complexities of the manufacturing process has resulted in an urgent shortage for hi...

Continuous bioprocessing facilities can be more cost-effective than stainless steel batch plants when total out-of-pocket costs across development and commercial activities are factored in, according to a study.

Connectivity of unit operations is a key enabler for continuous manufacturing to deliver benefits of not only improved mass throughput, but ultimately reduced COGS and increased facility utilization, says Merck.

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 f...

Takara Bio Europe has announced a licensing agreement with Denmark’s PanCryos, a pre-clinical stage biotech company, for its clinical-grade human embryonic stem (hES) cell lines, starting material for cell therapy development.