Author Archives: Dan Stanton

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…

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

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…

Sarepta: ‘We have a voracious appetite for gene therapy manufacturing capacity’

Inhouse capabilities coupled with capacity at CDMOs including Thermo Fisher and Catalent have allowed Sarepta Therapeutics to rapidly advance its gene therapy pipeline, says management. Sarepta Therapeutics has 43 programs in its pipeline, the majority of which are gene therapies and gene editing-based products. Leading gene therapy candidates include SRP-9001 Micro-dystrophin for Duchenne muscular dystrophy [DMD] and SRP-9003 for limb-girdle muscular dystrophy (LGMD). To support these developmental programs, the firm adopted two years ago what it calls “a hybrid manufacturing…

Avid preps to kick-off $30-40m manufacturing expansion

Though no date has been set, Avid Bioservices says it is undertaking pre-engineering and design work on a long-awaited facility aimed at supporting soaring demand for biomanufacturing services. For a while, contract development and manufacturing organization (CDMO) Avid Bioservices has been pushing to build out its Myford, California production facility to prepare for continued high demand from the biologics sector. But on its latest financial call, management said the firm is readying itself for the expansion in preparation for growth…

COVID programs could commandeer CDMO capacity, warns industry group

CDMO advocacy group the PBOA says regulatory and end-user flexibility will be key in addressing bottlenecks caused by the pressing need for COVID-19 vaccine and therapy capacity. Industry’s rapid push to develop therapies and vaccines against COVID-19 caused by the coronavirus SARS-CoV-2 has led to many announcing production deals with contract development and manufacturing organizations (CDMOs). For example, Moderna Therapeutics, for its late-stage mRNA vaccine, has secured production capacity with Catalent and Lonza. Meanwhile, it is becoming increasingly hard to…

CSL Behring strengthens gene therapy ambition in $450m deal

UniQure will continue manufacturing hemophilia gene therapy candidate AMT-061 after selling the licensing rights to CSL Behring. CSL Behring has paid uniQure $450 million for the global rights to commercialize the adeno-associated virus (AAV) gene therapy candidate AMT-061 (etranacogene dezaparvovec), in late stage studies for the treatment of hemophilia B. UniQure could be entitled to up to $1.6 billion depending on the progress of the candidate. The addition to CSL Behring supports the firm’s advanced therapy ambitions, according to company…