January 28, 2021
Ajinomoto Bio-Pharma Services says an expanded fill/finish contract for Humanigen’s COVID-19 antibody candidate lenzilumab will provide cost and time savings.
This week the contract development and manufacturing organization (CDMO) said it “will assume a key role in simplifying the supply chain efforts for Humanigen by providing drug product aseptic fill finish services at its San Diego facility to support continued clinical trial efforts through potential commercialization.”
Ajinomoto spokeswoman Stephanie Harrison told us, “We will provide streamlined and quality fill finish services of their product by leveraging our manufacturing and regulatory expertise, thereby providing cost and time savings, in addition to flexible and responsive support.
Image: iStock/libre de droit
“There is potential simplify the supply chain further by utilizing Aji Bio-Pharma’s commercial labelling and packaging capabilities,” she continued, adding, “We will not need to add extra capacity [to service] the deal.”
She declined to comment on the financial impact of the deal, but did confirm Ajinomoto will be providing fill finish services for this product if it is granted an emergency use authorisation (EUA) or fully approved.
The expansion comes days after Humanigen teamed up with the US Department of Defense (DoD) and the Biomedical Advanced Research and Development Authority (BARDA) to further develop lenzilumab for COVID-19.
The DoD deal “provides Humanigen with access to manufacturing capacity reserved by BARDA for fill-finish product to accelerate the drug product manufacturing of lenzilumab.”
Harrison told us Ajinomoto’s new agreement is not related to the DoD deal.
Lenzilumab is being developed to treat the immune hyper-response – known as a “cytokine storm” – observed in some patients hospitalized with COVID-19.
According to the Clinicaltrials.gov website Humanigen is currently enrolling patients in a Phase III study of the drug in the US and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.
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