Author Archives: Dan Stanton

Moderna contracts Lonza to help scale up COVID-19 mRNA vaccine candidate

Lonza will begin producing batches of mRNA-1273 from its site in New Hampshire in July as Moderna looks to achieve its goal of one billion doses of the potential COVID-19 vaccine annually. Moderna Therapeutics’ mRNA-1273 is one of the frontrunners in the race to develop a vaccine against the coronavirus (SARS-CoV-2). The messenger RNA (mRNA)-based candidate entered Phase I clinical trials in March, and last week Moderna submitted an Investigational New Drug (IND) application for Phase II and late-stage studies.…

AstraZeneca teams with Oxford University, enters COVID-19 vaccine race

AstraZeneca plans to leverage its global network to support production of an adenovirus vaccine vector (AAV) currently in Phase I trials against COVID-19. Based on an adenovirus vaccine vector (AAV) and the SARS-CoV-2 spike protein, the ChAdOx1 nCoV-19 entered clinical trials in Oxford, UK last week. Developed by the Jenner Institute and the Oxford Vaccine Group, at the University of Oxford, trial material has been produced by the Clinical BioManufacturing Facility (CBF) for the Nuffield Department of Medicine and speaking…

Catalent to provide large-scale fill/finish for J&J coronavirus vaccine project

Catalent, the latest CDMO to support Johnson & Johnson’s COVID-19 vaccine candidate, will carry out aseptic vial filling and packaging from its site in Bloomington, Indiana. Johnson & Johnson (J&J) began working on its vaccine strategy to combat COVID-19 – caused by the novel coronavirus (SARS-CoV-2) – in early January, identifying last month a lead candidate and two backups based on Janssen’s AdVac viral vector and PER.C6 cell line technology. As the programs move towards the clinic, J&J has been…

Pierre Fabre offloading MAb plant as it moves away from contract manufacturing

French drugmaker Pierre Fabre says contract manufacturing is not a priority as it looks to sell two facilities to CDMO Fareva. The two facilities Pierre Fabre is hoping to offload are an oncology injectable plant in Pau, and a monoclonal antibody production plant in Saint-Julien-en-Genevois, both in France. Both have been making products for others. Pierre Fabre focus is not on being a contract development and manufacturing organization (CDMO), said spokesperson Valérie Roucoules and so the decision to sell the…

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…