Author Archives: Dan Stanton

Moderna: How to make 1 billion doses of a COVID-19 vaccine

The right levels of capacity, equipment, staff, and raw materials are key in scaling up COVID-19 vaccine manufacturing says Moderna, which is moving towards making one billion doses of its mRNA candidate. Moderna Therapeutics’s mRNA-1273 is one of the frontrunners in the rush to develop a vaccine against COVID-19. The candidate is in Phase III trials and as such Moderna has focused much of its attention on building up its manufacturing capabilities to produce millions of doses, with a target…

With no biopharma slowdown in sight, Cytiva plans $500m operational boost

Cytiva’s five-year manufacturing growth strategy includes expanding facilities and 24/7 shift patterns to support continued double-digit biopharma growth and a COVID-19 tailwind In April, Danaher Corporation completed its $21 billion acquisition of General Electric’s (GE’s) Healthcare Life Sciences business and five months later the division – renamed Cytiva – has laid out an aggressive growth strategy to deal with demand for its bioprocess equipment and services. “Cytiva is deploying a multi-pronged approach to expand our global manufacturing capacity,” Emmanuel Ligner,…

Manufacturing shift to Ireland frees up US capacity for Regeneron’s COVID antibodies

Regeneron is shifting production of non-COVID therapies from its US facilities to its site in Limerick, Ireland to make space for a potential antibody cocktail against COVID-19. Regeneron’s efforts to combat COVID-19, caused by the novel coronavirus (SARS-CoV-2), is a monoclonal antibody (mAb) cocktail treatment based on potency and binding ability to the SARS-CoV-2 spike protein. The prospective therapy, REGN-COV2, developed using technology and experience demonstrated by the firm’s investigational triple antibody cocktail treatment for Ebola REGN-EB3, is is in…

ADC approval flurry a driver in MilliporeSigma $65m WI expansion

With five US FDA approvals over the past 15 months, MilliporeSigma says it is confident that antibody-drug conjugates (ADCs) will continue to be a driver of new therapeutics for years to come. A $65 million expansion in Wisconsin aims to exploit this. The Madison, Wisconsin expansion will bring MilliporeSigma’s contract manufacturing wing large-scale manufacturing capacity for high-potent active pharmaceutical ingredients (HPAPIs). The 70,000 square-foot facility will be designed to handle single-digit nanogram occupational exposure limit materials and will incorporate containment…

As COVID disrupts FDA inspections, will liso-cel approval be further delayed?

Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…

Automation: ‘The only way to truly scale cell therapy manufacture’ says Lonza

Lonza says it has achieved a significant milestone with partner Sheba Medical treating its first patient with a CD19 CAR-T cell immunotherapy made using the automated point-of-care Cocoon technology. In March 2019, Swiss CDMO Lonza entered a partnership with Israel’s Sheba Medical Center to provide automated and closed CAR-T manufacturing using its point-of-care (POC) Cocoon cell therapy manufacturing platform. This week, Sheba and Lonza announced the first patient has been dosed with a CD19 CAR-T cell immunotherapy made using the…

Thermo-stability could give DNA vaccine advantage in COVID-19 race, says Inovio

Inovio says the long shelf life and tolerance to heat of its DNA vaccine candidate could set it apart from the mRNA, protein, and viral-based COVID-19 vaccines in development. Inovio’s COVID-19 vaccine INO-4800 is composed of synthetic, circular DNA plasmids that encode parts of the viral protein. The candidate is in Phase I trials but Inovio is looking to initiate Phase 2/3 studies later this month, subject to US Food and Drug Administration (FDA) clearance. The candidate lags behind other candidates…

Bridgewest gains CDMO biz through Pfizer pegfilgrastim plant buy

Bridgewest Group will manufacture products for previous owner Pfizer among others after acquiring a microbial manufacturing plant in Adelaide, Australia. Bridgewest Group has made numerous investments in life sciences companies, but the acquisition of the Pfizer facility in Adelaide by subsidiary Bridgewest Australia Holdings marks the first expansion into the contract biologics space. Previous investments include antibody developer BioAtla and third-party pharma services firm BioDuro. According to Ian Wisenberg, CEO of Bridgewest Australia Biotech, the biologics contract development and manufacturing…

Adios AveXis: Novartis embeds $8.7bn acquisition into gene therapy rebrand

Gene therapy developer AveXis will be known as Novartis Gene Therapies, more than two years after being acquired by the Swiss biopharma giant. In May 2018, Novartis spent $8.7 billion to acquire gene therapy technology and therapy developer AveXis. Since then, Novartis has supported the commercialization of its spinal muscular atrophy (SMA) single-dose therapy Zolgensma (onasemnogene abeparvovec), while investing heavily into the bolt-ons manufacturing capabilities. In February, AveXis/Novartis opened a $115 million gene therapy production plant in Durham, North Carolina.…

MilliporeSigma adding 160 jobs to expanded NH filtration plant

MilliporeSigma will run a recently expanded facility in Jaffray, New Hampshire on a 24-hour cycle due to increased demand for filtration devices and membranes, driven in part by COVID-19. In June 2019, MilliporeSigma – the bioprocessing business unit of Germany’s Merck KGaA – announced plans to expand its site in Jaffrey, New Hampshire. The site produces a variety of filtration devices and membranes that support the life science industries and the manufacture of biopharmaceuticals. The 35,800 additional square feet of…