Author Archives: Dan Stanton

Sanofi sets out COVID-19 vaccine scale-out plans for protein and mRNA candidates

There are 94 COVID-19 vaccines in development but almost no capacity to produce them at meaningful scale says Sanofi, which is aiming to go from 100 million doses of a recombinant protein candidate to a billion in 12 months. Industry’s response to coronavirus (SARS-CoV-2) has been, to use the word of the moment, unprecedented. Scores of COVID-19 vaccines are in various stages of development. Sanofi is involved in two vaccine programs, representing a “huge opportunity for our organization,” CEO Paul…

MicrofluidX to take on single-use tech with microfluidics for CGTs

MicrofluidX will use fundraising money to advance its cell bioprocessing technology, which uses microfluidics to tackle challenges associated with bioprocessing advanced therapies. The London, UK-based firm has raised £1.4 million ($1.7 million) in seed funding to advance its microfluidics-based technology, which aims to combat challenges associated with the production of cell and gene therapies (CGTs) such as cost of goods, batch variability, and scalability. “Cell and gene therapies have demonstrated significant therapeutic potential. However, these treatments are now at a…

Emergent to produce J&J COVID-19 vaccine in $135m contract

As it prepares to advance its COVID-19 vaccine candidate, J&J has contracted CDMO Emergent Biosolutions and reserved large-scale capacity at its site in Maryland. In its efforts to tackle the novel coronavirus (SARS-CoV-2), Johnson & Johnson (J&J) began working on a vaccine candidate in early January and last month identified a lead COVID-19 vaccine candidate and two backups. To prepare for trials and future approval, the firm has inked a deal with contract development and manufacturing organization (CDMO) Emergent BioSolutions…

Eli Lilly and AbCellera begin GMP manufacture of potential COVID-19 MAb

Eli Lilly has three therapy programs attempting to combat COVID-19 but says its monoclonal antibody partnership with AbCellera is the most significant. In March, Eli Lilly inked a deal to codevelop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus, using AbCellera’s pandemic response platform. While discussing its first quarter 2020 results, Lilly described the collaboration as the “most significant program” of its active therapeutic programs it is pursuing against COVID-19 and…

Oxford University latest horse in COVID-19 race as AAV vaccine enters clinic

The first patients have been dosed with ChAdOx1 nCoV-19, an adenovirus vaccine vector (AAV) developed by the Jenner Institute at the University of Oxford. It becomes the fifth COVID-19 vaccine to enter the clinic. Clinical trials of the vaccine, based on an adenovirus vaccine vector (AAV) and the SARS-CoV-2 spike protein, began today in healthy volunteers aged between 18 – 55 in Oxford, UK. The vaccine was developed at Oxford’s Jenner Institute and was chosen as the most suitable vaccine…

Sartorius’ strong Q1 shows ‘defensiveness of bioprocess industry,’ analysts

Sartorius reported pronounced year-on-year increases in sales and orders for its first quarter 2020, indicating the opportunities for bioprocessing and the resilience of biopharma amid the coronavirus pandemic. For many businesses, the first quarter 2020 could be described as exceptional; at best subdued, but more realistically unsettling or even disastrous. Since January, the novel coronavirus (SARS-CoV-2) has led to systematic shutdowns and lockdowns, creating fiscal uncertainty and forcing many businesses to shut up shop. But for Sartorius Stedim Biotech, the…

MilliporeSigma invests $110m in gene therapy CMDO biz

MilliporeSigma is building a second facility at its gene therapy site in California, adding 11 production suites and more than doubling its viral vector capacity. The life sciences services division of Merck KGaA, MilliporeSigma, has been involved in the gene therapy area since 1997 through its site in Carlsbad, California. In 2016, the company expanded the site from 44,000 square feet to 65,000 square feet to meet growing demand for viral and gene therapy products. Now the firm has announced…

FairJourney and Iontas: Speed and collaboration key to developing coronavirus antibodies

Antibodies must be developable and manufacturable say FairJourney and Iontas, the latest partnership aiming to bring a therapy against COVID-19 to fruition. Recently we published a comprehensive guide to all the antibody-based therapies being developed to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). The latest firms looking to this modality in the battle against the virus are UK-based biotech Iontas and Portugese contract research organization (CRO) FairJourney Biologics, which announced a partnership to combine the latter’s phage display antibody…

COVID-19 pipeline: Industry flexing its Abs in fight against coronavirus

From Regeneron to GSK, monoclonal to bispecific, industry is increasingly looking at antibody (Ab) therapies to tackle the novel coronavirus. We bring you a comprehensive guide to what’s in the pipeline. Only six weeks ago, Bioprocess Insider brought to you a highlights reel of the treatments and prophylaxis in the development pipeline to treat COVID-19, caused by the novel coronavirus (SARS-CoV-2). But six weeks is a very long time in a global pandemic, and since then new projects have begun…

Over-capacity concern drives Bellicum to sell Texas CAR-T plant for $15m

The University of Texas MD Anderson Cancer Center has acquired the 60,000 square-foot Houston facility and entered into an agreement to manufacture cellular therapies for Bellicum Pharmaceuticals. The $15 million (€13.8 million) sale, first announced in January, went through this week and sees MD Anderson Cancer Center take over operations at the Houston, Texas site less than a year after Bellicum completed the buildout of the manufacturing space. The sale took place following an evaluation of Bellicum’s manufacturing strategy as…