GAITHERSBURG, MD. and BURLINGAME, CA. – Jan. 25, 2021 — Emergent BioSolutions Inc. (NYSE:EBS) (Emergent) and Humanigen, Inc. (NASDAQ:HGEN) (Humanigen) today announced that they have entered into a contract development and manufacturing (CDMO) services agreement to accelerate the drug product manufacturing of lenzilumab™, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm.” Emergent will provide access to manufacturing capacity reserved for and provided by the U.S. government under Humanigen’s Cooperative Research and Development Agreement (CRADA) with the Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. Lenzilumab is currently in a Phase 3 clinical trial evaluating patients hospitalized with COVID-19. Humanigen intends to file for emergency use authorization (EUA) in the first quarter of 2021.
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Humanigen and Emergent BioSolutions Announce Contract Development and Manufacturing Agreement for Phase 3 COVID-19 Therapeutic Candidate Lenzilumab™
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Excerpt taken from BioPharm International October 2020 Regulatory Sourcebook article titled: GMPs Guide COVID-19 Vaccine Manufacturing.
“The FDA Guidance highlights the pertinent CGMP [current good manufacturing practice] considerations for all vaccine manufacturing and serves as a reminder of statutory GMP expectations for COVID-19 vaccines specifically,” says Karolyn Gale, senior director, regulatory affairs, Emergent BioSolutions."
View the full article here.
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Jee Look, senior director of drug product development for Emergent BioSolutions recently contributed to an article in Pharmaceutical Technology titled, "Factoring Stability in the Biological Drug Mix."
Stability issues can also occur at any stage of a vaccine’s development lifecycle, according to Jee Look, senior director of drug product development for Emergent BioSolutions’ contract development and manufacturing organization (CDMO) business. “In some cases, instability that occurs during upstream/downstream processing can be mitigated during final drug product manufacturing, but it is important to identify and understand the mechanisms of instability early in the pre-formulation stage as instability in the final drug product would have the largest impact on patient safety and overall production efficiency and would be more costly to fix,” he says.
With ongoing advances in science and technology, the cell and gene therapy pipeline has grown especially robust over the past few years. At present, Clinical Trials.gov shows more than 4,500 active gene therapy trials globally. In the United States, McKinsey experts expect to see 10 to 20 cell and gene therapy approvals per year over the next five years.
This article discusses the important factors to consider when selecting an outsourcing partner for your advanced therapies.
Topics: advanced therapies
Emergent BioSolutions, a Wells Fargo Corporate & Investment Banking customer since 2011, helps governments respond to health emergencies before they happen. Eight years ago, they were planning for a crisis like Covid-19. America will need hundreds of millions of doses of a vaccine. Emergent is manufacturing them now, before they've been approved for use, so they'll be ready if they measure up.
Syed T. Husain, senior vice president and CDMO business unit head at Emergent BioSolutions recently contributed to an editorial titled, "Strategizing for Rapid Changeovers in Biologics Manufacturing" in the September issue of BioPharm International.
Read the full article here.
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“Emergent has a long, successful history of working with the US government to develop, manufacture, and deliver safe and effective medical countermeasures for public health. BARDA has been an excellent partner, across all levels from leadership to the project and technical teams with whom we work closely. As partners on a team, we work collaboratively to monitor, evaluate, and progress projects and help remove barriers that slow down the directive of Operation Warp Speed.”
Dino Muzzin, senior vice president of manufacturing operations at Emergent BioSolutions contributed to an editorial in the August issue of Pharmaceutical Technology on the pivotal role outsourcing partners are having in the rapid development and production of COVID-19 vaccine candidates.
Read the full article here.
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Dino Muzzin, senior vice president of manufacturing operations at Emergent BioSolutions recently contributed to an editorial in Pharmtech.com discussing the importance of collaboration between innovators, manufacturing partners, and the entire supply chain when preparing for rapid scale-up of COVID-19 vaccine candidates.
In a recent article with BioProcess International, Syed T. Husain, senior vice president & CDMO business unit head at Emergent BioSolutions, discusses the critical role Emergent has in supporting the development & manufacturing of COVID-19 vaccine candidates.