Global Markets

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

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

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

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

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

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…

How to avoid a post-COVID manufacturing crisis

How pharmaceutical companies should plan to catch up after the pandemic and explain what happened to inspectors. It is important to start planning for post-COVID-19 recovery even as the pandemic continues to impact pharmaceutical manufacturing operations, an expert panel told Food and Drug Law Institute members during a 19 May webinar. Manufacturers should set priorities in advance so they can attack the most important backlogged activities first. They also should approach recovery with the right mindset: the need to act…

In brief: GSK inks $231m ‘flexible’ deal with Samsung BioLogics

GSK says the eight-year agreement with the Korean CDMO brings additional and flexible capacity to manufacture its innovative biopharmaceutical therapies. UK-headquartered pharma giant GlaxoSmithKline (GSK) has an extensive manufacturing network to support its biologics product portfolio but has turned to contract development and manufacturing organization (CDMO) Samsung BioLogics to secure capacity for future needs. The deal will see Samsung Biologics provide GSK with additional capacity for large-scale biomanufacturing from its site in Incheon, South Korea. The capacity will be flexible…

AZ aims to ship Oxford’s COVID vaccine from September using BARDA’s $1bn

AstraZeneca says $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) will fund production of Oxford University’s SARS-CoV-2 vaccine. The Anglo-Swedish drug firm said it would begin production of the vaccine candidate – previously known as ChAdOx1 nCoV-19 and now called AZD1222 – in the autumn. It added that the BARDA funding will also support a support a Phase III trial involving 30,000 participants and a pediatric study. AstraZeneca set the funding as part of an effort to…

Continuous manufacturing back in second Act

House tries again to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era. The new HEROES Act legislation revives a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing that had earlier made it into the US House of Representatives’ version of the CARES Act but not the final enacted CARES pandemic relief law. The HEROES bill (HR 6800) authorizes $100 million for the centers of excellence, available until expended. That’s up from the $80…

Swiss biomanufacturing revived in 2019 says industry group

Swiss biomanufacturing had a “resurgence” in 2019 according to an industry group which cited plant investments by drug firms and CDMOs as growth drivers. The Swiss Biotech Association – which represents biopharmaceutical companies, biotech and the services sector – made the comments in a recently published report. It wrote that, “Switzerland’s manufacturing prowess has experienced a revival in 2019, following years of “exporting” manufacturing capabilities aboard.” The organization highlighted Biogen’s decision to invest CHF 1 billion ($1 billion) in a…