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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…

Fujifilm to make Warp Speed vaccine for Novavax from NC site

by Dan Stanton

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…

COVID-19 revenue key to Thermo Fisher’s revenue growth in Q2

by Gareth Macdonald

Thermo Fisher’s revenue increased 10% in the second quarter thanks to $1.3 billion generated by COVID-19 related work. Thermo posted revenue of $6.92 billion, up from $6.32 billion in the comparable quarter last year. Life sciences solutions contributed $2.60 billion – up from $1.71 billion – specialty diagnostics brought in $990 million – up from $940 million – and lab products and services generated $2.79 billion, up from $2.63 billion. In contrast, analytical instrument revenue was $1.05 billion, down from $1.32 billion…

Forge Bio’s combo model for gene therapies attracts $40m in funding

by Frank Vinluan

Forge Biologics has something rare for most early-stage biotech startups: revenue from customers. Now it has $40 million to expand its model, which places contract manufacturing alongside the development of its own gene therapies, the most advanced of which is being readied for tests in humans. From operations in Columbus, Ohio, Forge makes gene therapies for other companies. The company was initially conceived solely as a contract manufacturer, CEO Tim Miller told Xconomy. The explosion of gene therapy research is…

Catalent expands contract with Humanigen for COVID-19 MAb

by Dan Stanton

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…

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…

Samsung Biologics eyes fourth plant as capacity fills

by Dan Stanton

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

by Dan Stanton

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

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…

Rentschler and Vetter team to take on rising drug cost and complexity

by Gareth Macdonald

CDMOs Rentschler Biopharma and Vetter say demand for lower cost, more streamlined manufacturing services prompted partnership. The Germany-based contract development and manufacturing organizations (CDMOs) announced the formation of a strategic alliance on Monday. The idea is to offer customers Rentschler’s drug substance manufacturing capacity in combination with Vetter’s aseptic fill and finish and secondary packaging services. Rentschler spokeswoman Cora Kaiser cited market dynamics as the driver for the collaboration, explaining “Drug development is growing increasingly complex and cost intensive. Biopharmaceutical…