Author Archives: Dan Stanton

COVID-19: ‘Pandemic-ready’ set-up placing Emergent apart in CDMO space

Emergent BioSolutions is at the frontline of COVID-19, supporting vaccine candidate production for AstraZeneca, J&J, and others. Head of Emergent’s CDMO business explains why. Before January, the biologics contract development and manufacturing organization (CDMO) landscape was “very, very exciting,” Syed Husain, senior vice president and CDMO business unit head at Emergent, tells Bioprocess Insider over a Zoom interview. On the drug substance side, there was a healthy amount of demand for capacity coming from industry with a lot of opportunities…

Danaher: Integrating Cytiva in the time of coronavirus

Cytiva, the former GE Healthcare Life Sciences business, is “off to a blistering start” at Danaher, according to an analyst despite face-to-face restrictions imposed by COVID-19. For the second quarter 2020, Danaher Corporation reported revenues of $5.3 billon, up 19% year-on-year. This was attributed to high sales across its life sciences services divisions, including a boost from Cytiva – previously known as the Biopharma Business of GE Life Sciences – which Danaher acquired for $21 billion and became part of…

Kite flies high with second CAR-T approval

Gilead’s Kite has won US FDA approval for Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL). Tecartus becomes the third chimeric antigen receptor (CAR) T-cell therapy to be granted approval by the US Food and Drug Administration after Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), both of which were approved in 2017. Tecartus is designed to target CD19, a protein found in high amounts in cancerous B cells, and the regulatory decision…

Fujifilm to make Warp Speed vaccine for Novavax from NC site

With $1.6 billion of US government funds in hand, Novavax has contracted CDMO Fujifilm Diosynth Biotechnologies (FDB) to produce Phase III trial material for its COVID-19 vaccine candidate. Earlier this month, the US government handed Novavax – a firm with no approved products – $1.6 billion to progress the development of its vaccine candidate NVX‑CoV2373 against the novel coronavirus (SARS-CoV-2). Until a $2 billion deal was struck this week with Pfizer/BioNTech, the funding was the largest under the Operation Warp…

Novartis offering COVID-19 capacity but won’t play in vaccine space

Novartis has no plans to join its Big Pharma peers in developing a coronavirus vaccine but says it will continue supporting efforts to tackle the virus. Developing a vaccine is deemed key in the global fight against the novel coronavirus. As such, industry has mobilized to speed development efforts through the clinic, with numerous Big Pharma firms jumping on board. AstraZeneca is racing away in bringing its Oxford vaccine to fruition. J&J is pushing forwards with its adenovector-based vaccine. Pfizer…

Valneva to supply vero-cell based COVID vaccine to UK

Valneva will supply up to 100 million doses of a SARS-CoV-2 vaccine candidate and is looking to expand capacity at facilities in Scotland and Sweden. Under the terms of the deal, French vaccine firm Valneva SE will manufacture up to 100 million doses of its candidate VLA2001 as part of a UK government strategy to secure COVID-19 vaccines. Doses will be supplied from Valneva’s production site for other commercially available travel vaccines and candidates in Livingston, Scotland. “Today’s agreement from the UK…

Catalent expands contract with Humanigen for COVID-19 MAb

Catalent will provide end-to-end services to support lenzilumab in a Phase III study in COVID-19 patients. In May, Catalent announced it was clinically supporting Humanigen’s anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody lenzilumab for a Phase III clinical trials for COVID-19. This week, the contract development and manufacturing organization (CDMO) says it has expanded its work with Humanigen to include full end-to-end services for the candidate. “Humanigen and Catalent have been working together since 2007, but shifted focus earlier…

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…

Samsung Biologics eyes fourth plant as capacity fills

The 364,000 L of bioreactor capacity at Samsung Biologics’ site in Korea will be fully utilized by 2022, says the CDMO as it contemplates a new facility. Contract development and manufacturing organization (CDMO) Samsung Biologics has grown its site in Songdo, Incheon since its inception in 2011 with three plants hosting a total of 364,000 L of mostly stainless-steel bioreactor capacity. Plant number one has 30,000 L of capacity from six 5,000 L tanks. Plant number two offers 150,000 L…

Bionova building CA manufacturing plant to feed biologics demand

Having heard the demand from customers to add GMP biomanufacturing, Bionova has begun construction of a facility in Fremont boasting two 2,000 L single-use trains. Bionova Scientific has started to cement the ‘M’ in CDMO (contract development and manufacturing organization) after it broke ground on a 36,000 square-foot production facility last week at its site in Fremont, California. According to the firm, the “well-documented need for high-quality manufacturing capacity in the industry” helped drive the expansion, as did the call…