Author Archives: Dan Stanton

Gardasil scale-up unaffected by COVID capacity chase, says Merck

Merck says bringing two plants online to feed demand for its blockbuster Gardasil remains a priority, despite industry’s unparalleled need for vaccine capacity driven by COVID-19 projects. In January 2020, Merck & Co. (known as MSD outside North America) told delegates at the JP Morgan Conference in San Francisco that to keep up with the “incredible demand” for its human papillomavirus (HPV) vaccines Gardasil and Gardasil 9, two new production plants representing an investment of over $1.6 billion would come…

Lilly turns to Amgen to up COVID-19 antibody production

Amgen will provide manufacturing capacity to support scale-up of monoclonal antibody candidates being developed by Eli Lilly against COVID-19. Financial details of the deal have not been divulged but bringing fellow Big Pharma firm Amgen on board will “significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies,” the firms said in a statement. “Increasing the manufacturing capacity for our neutralizing antibodies through this collaboration with Amgen is a crucial next step, and together we hope to be able…

Takeda opens MA manufacturing unit to support cell therapy R&D

The 24,000 square-foot cell therapy manufacturing facility will produce material through to Phase IIb trials, supporting Takeda’s cell therapy ambitions. In 2019, Takeda expanded its presence in the oncology cell therapy space inking a series of deals and establishing an internal translational cell therapy engine. To support this, the firm invested in a cell therapy manufacturing center at its R&D headquarters in Boston, Massachusetts which opened this week. “The R&D cell therapy manufacturing facility will produce cell therapies for clinical…

Exelixis: Deals with NBE and Catalent bring multi-pronged ADC approach

The antibody-drug conjugate (ADC) space has evolved significantly from its first-generation of products says Exelixis, which is increasing its presence in the sector through a pair of deals. “Exelixis has a long history of success in small molecule drug discovery and development, rooted in an approach that focuses on understanding cancer biology and applying our expertise and technology to build therapies that address it,” Peter Lamb, chief scientific officer at Exelixis, told this publication. Cabometyx (cabozantinib), Cometriq (cabozantinib), Cotelic (cobimetinib)…

Novavax teams with Serum for mass vaccine supply: ‘We can’t do that, they can’

Novavax has contracted India’s Serum Institute to make more than a billion doses of its protein-based COVID-19 vaccine candidate, pushing total capacity to 2 billion doses across its network. NVX-CoV2373 is a potential vaccine against the COVID-19 consisting of a prefusion protein made using Novavax’ nanoparticle technology based on infecting Sf9 insect cells with baculovirus viral vectors that express the SARS-CoV-2 spike protein. The vaccine is also being tested with Novavax’ Matrix M adjuvant, a saponin-based adjuvant that acts in…

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…