Emergent BioSolutions has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA) valued at $19.7 million to develop and manufacture cGMP lots of three Ebola monoclonal antibodies in Chinese hamster ovary (CHO) cell lines at a 2,000-liter scale. This contract is the first BARDA Task Order for an Ebola countermeasure awarded to Emergent under the Center for Innovation in Advanced Development and Manufacturing (CIADM) program. Under the scope of this two-year contract, the company will conduct process development, analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance.

The monoclonal antibodies will be manufactured at Emergent’s Bayview Campus in Baltimore, which is equipped with disposable manufacturing technology. In 2012, the facility was designated by the US Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing, which allows the company to contract with the US government through task order requests for requirements such as operational readiness, development, and manufacturing of CBRN products, warm base maintenance, surge manufacturing, and workforce development. In this facility, Emergent has manufactured product candidates for the company’s pipeline and for ongoing collaborations, including most recently the MVA-EBOZ Ebola vaccine candidate, which is now being evaluated in a Phase I clinical study.

Emergent BioSolutions is a specialty biopharmaceutical company that develops and manufactures medical countermeasures for biological and chemical threats as well as for infectious diseases. The company also develops and commercializes therapeutics and other specialty products for hospitals and clinics for hematology/oncology, transplantation, infectious diseases, and autoimmune disorders. The company also offers contract manufacturing services for both bulk drug substances and sterile injectable drug products.

Source: Emergent BioSolutions