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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…

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…

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…

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…

Instant caRNA? Tesla touts RNA bioreactor it is developing with Curevac

by Gareth Macdonald

Curevac and car maker Tesla claim their development RNA production tech is less labour intensive and more deployable than alternatives. The technology – described as a Bioreactor for RNA in vitro Transcription – allows the DNA templates from which the RNA is produced to be used multiple times. It is also automated, which Curevac and Tesla say will minimize handling steps and make manufacturing processes more robust. The firms contrast their technology with current systems, which involve “many separate manufacturing…

CSL Behring strengthens gene therapy ambition in $450m deal

by Dan Stanton

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…

Sanofi pays Translate $425m to expand mRNA partnership

by Dan Stanton

The deal expands upon a 2018 collaboration and comes as Translate Bio builds out its mRNA vaccine production facilities in Massachusetts. In 2018, French pharma giant Sanofi teamed up with Translate Bio to develop messenger RNA (mRNA) vaccines for up to five infectious disease pathogens for an initial three-year period. This week, the firms have announced the collaboration will be expanding. mRNA vaccines work by delivering a nucleotide sequence that codes for the proteins that pathogens use to cause disease.…

Nex-T up: Bristol-Myers using machine learning to optimize future CAR-T

by Dan Stanton

Bristol-Myers Squibb says its next-generation CAR-T candidates, known as Nex-T, could offer faster and cheaper autologous cell therapies against multiple myeloma and lymphoma. Bristol-Myers Squibb (BMS) entered the chimeric antigen receptor (CAR) T-cell therapy space through the completion of its $74 billion acquisition of Celgene last November. Among the candidates BMS added to its pipeline were lisocabtagene maraleucel (liso-cel), an anti-CD19 targeting lymphoma, and idecabtagene vicleuce (ide-cel) being developed against multiple myeloma in partnership with Bluebird Bio, both in late-stage…

Emergent to add gene therapy capacity through $75m plant expansion

by Gareth Macdonald

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector. The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts. At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000. Emergent said the investment will establish a multi-suite production operation with 1,000…