CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Lonza and Thermo Fisher Scientific.
Lonza, Humanigen in Mfg Pact for COVID-19 mAb Candidate
Lonza and Humanigen, a clinical-stage biopharmaceutical company, have entered into a strategic collaboration to expand the manufacturing capacity for lenzilumab, currently in Phase III clinical trials for COVID-19, in advance of potential emergency use authorization in 2020 and subsequent commercialization.
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 collaboration provides Humanigen with additional capacity from Lonza for cGMP production of lenzilumab with operations intended to start in 2021. Production of lenzilumab will begin at Lonza’s 2,000-L manufacturing facilities in Hayward, California. Technology transfer is expected to begin in the third quarter of 2020. The collaboration is projected to take lenzilumab through product launch and commercial supply.
Earlier this month (September 2020), Humanigen reported that its Phase III registration trial of lenzilumab in patients with COVID-19 was unanimously recommended for continuation without modification by an independent data safety monitoring board after a planned interim analysis. Humanigen says it expects to complete the targeted enrollment of 300 patients this month (September 2020) with topline data available in the fourth quarter of 2020.
Thermo Fisher Expands Consumables Production for COVID-19 Projects
Thermo Fisher Scientific is investing more than $140 million to further expand its laboratory plastics consumables production to support COVID-19 testing and development and manufacturing of therapies and vaccines.
The Thermo Fisher sites currently being expanded are in the following: Rochester, New York; Petaluma, California; Monterrey and Tijuana, Mexico; and Joensuu, Finland.
The increase in production related to COVID-19 testing and development and manufacturing of therapies and vaccines, has created demand for laboratory plastics, including pipette and automation tips, storage tubes and plates, transfer pipettes, and packaging vials and bottles. Thermo Fisher says it is creating more than 1,000 jobs across manufacturing sites globally, increasing automation capabilities, and optimizing warehouse and sterilization capacity, to improve supply-chain agility.
The company’s consumables support COVID-19 work globally and include sample collection vials for diagnostic test kits, pipettes for test processing, lab essentials for research into therapies and vaccines, lab plastics to support clinical and epidemiological studies, and materials for vaccine production and biobanking.
Source: Thermo Fisher Scientific