CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Thermo Fisher Scientific and Hovione.
Biologics Manufacturing
Thermo Fisher, Humanigen in Mfg Pact for COVID-19 mAb Candidate
Thermo Fisher Scientific and Humanigen, a clinical-stage biopharmaceutical company, have entered into a strategic collaboration to expand the manufacturing capacity for Humanigen’s lenzilumab, currently in Phase III clinical trials for COVID-19, to support a potential emergency use authorization (EUA).
Lenzilumab is a granulocyte macrophage-colony stimulating factor monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
This multi-year manufacturing partnership adds to Humanigen’s large-scale commercial production efforts, including recently announced partnerships with Lonza and Catalent, in advance of a potential 2020 EUA and subsequent commercialization of lenzilumab. Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process, and commercial-scale production could begin before the end of this year (2020).
Source: Humanigen
Hovione To Produce Cyclodextrin for Ligand’s COVID-19 Drug
Hovione has signed a partnership agreement with Ligand Pharmaceuticals, a San Diego-based biopharmaceutical company, to ramp up production of Ligand’s Captisol, a proprietary chemically modified cyclodextrin designed to optimize the solubility and stability of drugs, which is used in the formulation of Gilead Sciences’ Covid-19 treatment, Veklury (remdesivir).
Hovione is the sole producer of this enabling excipient. Ligand’s Captisol technology is a modified cyclodextrin, with a chemical structure that was designed to improve solubility, stability, bioavailability, and dosing of active pharmaceutical ingredients (APIs).
Gilead’s Veklury is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens. Multiple ongoing international Phase III clinical trials are evaluating the safety and efficacy of Veklury for the treatment of SARS-CoV-2, the virus that causes COVID-19, in different patient populations, formulations, and in combination with other therapies. The US Food and Drug Administration expanded the emergency use authorization enabling use of the investigational antiviral Veklury to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
Source: Hovione
