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With capacity assured and platform proven, hopes grow for J&J COVID vaccine

J&J is confident of the success and supply of its COVID-19 vaccine candidate after securing manufacturing capacity and receiving approval of Ebola vaccines based on the same adenovector technology. Johnson & Johnson’s candidate – SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant – is set to enter Phase I/IIa studies later this month (see textbox). It is one of a number of coronavirus vaccines in development but according to the firm, the candidate’s potential for success has been bolstered by the verification of the…

Blockchain ideal for coronavirus vaccine distribution, says expert

by Gareth Macdonald

Blockchain tech is ideal for SARS-CoV-2 vaccine supply chains according to an expert who says efficiency and trust are vital. In the six or so months since SARS-CoV2 – the causative agent of COVID-19 – was detected, public health efforts have focused on finding ways to slow the spread of the virus until a vaccine could be developed. In parallel vaccine developers have accelerated their efforts. According to the World Health Organisation (WHO) there are 23 candidate SARS-CoV2 jabs in…

Amgen invests further $421m in China’s Beigene

by Sarah de Crescenzo

Amgen has upped its investment in drugmaker Beigene to further access the increasingly large pharmaceutical market, China. Last year, Thousand Oaks, California-based Amgen closed a strategic collaboration with BeiGene, investing $2.8 billion to gain a presence in what’s becoming an ever-more essential market for global drug development. The investment earned it an R&D pact and ownership of about one-fifth of the Chinese oncology drug company. Now the firm has snapped up a chunk of additional shares in a move to maintain its…

Moderna adds Rovi to roster of coronavirus vaccine CDMOs

by Gareth Macdonald

Rovi has joined the list of CDMOs that will make Moderna’s coronavirus vaccine candidate if it is approved. Rovi – also known as Laboratorios Farmacéuticos Rovi – will provide commercial fill-finish and packaging services for mRNA-1273 at its facility in Madrid, Spain under a contract announced last week. Moderna said Rovi would support production of hundreds of millions of doses to supply markets outside of the US starting in early 2021. The US firm also said ROVI would hire extra manufacturing operations and…

Novavax says COVID $1.6bn funding helps secure US-based supply chain

by Dan Stanton

The ‘Operation Warp Speed’ $1.6 billion funding boost will help support the large-scale manufacture of COVID-19 vaccine candidate NVX‑CoV2373, says Novavax. Novavax has become the beneficiary of the largest funding by Operation Warp Speed – the US government’s response to the expedite vaccines and therapeutics against the novel coronavirus – to date, receiving $1.6 billion it says will be used to aid clinical development and secure manufacturing for NVX‑CoV2373. “In addition to establishing scale-up manufacturing capacity to deliver 100 million…

Manufacturing pace key for COVID-19 vaccines hoping to jump to ‘Warp Speed’

by Sarah Karlin-Smith

Ease of manufacturing scale up may determine which candidates advance furthest in the US government’s partnership with industry to speed COVID-19 vaccines to patients. Senior government officials also discussed approval standards, how a vaccine would be distributed, and how much the government and Americans could pay in a 16 June press call. The ability for a COVID-19 vaccine to be manufactured quickly and at scale will be a key factor in determining which potential candidates advance through Operation Warp Speed,…

Inhouse and out: AstraZeneca secures COVID-19 vaccine capacity

by Dan Stanton

Contracts with CDMOs Catalent, Emergent Biosolutions, Cobra, and Novasep and the retrofitting of a facility in Ohio will support AstraZeneca and the Oxford University’s COVID-19 vaccine candidate. AstraZeneca was among the second wave of Big Pharma firms to enter the rush to develop a vaccine against the coronavirus SARS-CoV-2 that causes COVID-19 in April when it teamed with the Jenner Institute and the Oxford Vaccine Group at the University of Oxford on its ChAdOx1 nCoV-19 program. Production of the vaccine…

Samsung Biologics selects San Francisco for first US facility

by Dan Stanton

Korean CDMO Samsung Biologics will open an R&D lab in the San Francisco area later this year, though admits to delays due to COVID-19. Contract development and manufacturing organization (CDMO) Samsung Biologics has established itself as a large-scale biologics producer from its base in Incheon, South Korea. Along with 364,000 L of bioreactor capacity, the firm expanded its services in 2017 to include cell line and process development (PD) services. And now the firm is coming to the US. Eagle-eyed…

CSL to make ‘molecular clamp’ enabled COVID-19 vaccine for University of Queensland

by Dan Stanton

A part-CEPI funded COVID-19 vaccine will be made by CSL at its site in Melbourne, Australia and will incorporate the MF59 adjuvant made by CSL subsidiary Seqirus. In January, the University of Queensland (UQ), Australia received funding of up to $10.6 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to help develop its vaccine against COVID-19, caused by the novel coronavirus (SARS-CoV-2). The candidate is based on proprietary the University’s proprietary “molecular clamp” vaccine platform, a technology that aims…

Fujifilm invests $928m to double capacity at ex-Biogen plant, adding 300 jobs

by Dan Stanton

Fujifilm Diosynth Biotechnologies will increase bioreactor capacity to 240,000 L at the recently acquired site in Denmark, feeding the high demand for biomanufacturing services. In March 2019, Fujifilm Diosynth Biotechnologies (FDB) announced plans to buy a mammalian cell culture manufacturing facility in Hillerød, Denmark from biopharma firm Biogen. In August, the firms completed the $890 million deal. The acquisition was the largest investment both in terms of financials and in terms of capacity for the Fujifilm Corporation subsidiary, but 10…