Author Archives: Dan Stanton

Regeneron clears capacity at NY plant in prep for COVID antibody cocktail

Regeneron says depending on trial data it could be producing hundreds of thousands of doses of an antibody cocktail against COVID-19 by the end of summer. Regeneron was one of the first to announce its intentions to develop monoclonal antibodies (MAbs) against COVID-19, caused by the novel coronavirus (SARS-CoV-2). Using its VelociSuite discovery and development technologies and experience garnered to develop its investigational triple antibody cocktail treatment for Ebola REGN-EB3, the firm has is focused on developing a multi-antibody ‘cocktail’…

Univercells on balancing its bioprocess tech and CDMO subsidiaries

Univercells has launched a bioprocess technology subsidiary it says can offer a new generation of biomanufacturing platforms that can solve industry’s manufacturing challenges. It has been a busy few months for Belgium-based biologics platform firm Univercells. In February, global investment firm KKR – through its portfolio of life sciences tools companies Gamma Biosciences – committed €50 million ($54 million) into the firm Univercells. Then last month, the firm launched Exothera, a process development and viral vector contract development and manufacturing…

With Arcturus mRNA, Catalent bags another COVID vaccine project

Catalent will make scaled-up batches of Arcturus Therapeutics’ mRNA vaccine candidate from a customized suite at its Madison, Wisconsin facility. The CDMO says it has been presented with around 100 opportunities to support COVID-19 development projects. Under terms of the deal, financials of which have not been divulged, contract development and manufacturing organization (CDMO) Catalent will make Arcturus’ COVID-19 messenger RNA (mRNA) vaccine candidate LUNAR-COV19 to support clinical trials. The potential single-shot vaccine uses Arcturus’ STARR Technology platform, which combines…

Swiss site set to make Biogen Alzheimer’s MAb from 2021

Biogen says construction of its manufacturing site in Switzerland is complete and will produce commercial supply of aducanumab if the potential Alzheimer’s blockbuster is approved. Biogen has had a turbulent time with its proposed Alzheimer’s disease monoclonal antibody aducanumab. In 2015, data was announced that led the company to outline a Phase III study. Then in March 2019, late-stage results prompted Biogen to shelve the drug. Months later, the firm resurrected the program, after “new analysis of a larger dataset”…

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…