Hemispherx Biopharma Inc. said it has encountered delays associated with the supply of blood derived leucocytes essential to the Alferon manufacturing process. Hemispherx was recently informed by BioLife Plasma Services, a subsidiary of major U.S. player Baxalta, that it was, without cause, terminating its sole source contract with Hemispherx prior to the termination date because it was departing that particular area of its business being conducted under the d/b/a Penn Plasma. The Hemispherx team has aggressively moved to replace the Baxalta subsidiary, negotiating for direct supply agreements with various blood centers around the country to assure an uninterrupted supply of leukocytes to manufacture Alferon. These agreements, once entered, will allow the company to start receiving the necessary supply of raw materials to continue the validation of the manufacturing facility in New Brunswick to produce commercial grade Alferon. The first such contract has been entered with Gulf Coast Regional Blood Center.
The breach by BioLife was particularly damaging for Hemispherx since Hemispherx is in the process of revalidating its facility that manufactures Alferon N Injection and the long-term contract with BioLife d/b/a Penn Plasma for blood supply is a critical component to the manufacturing process.
"BioLife's decision to shut down its Penn Plasma business arm before meeting BioLife's contract obligations to Hemispherx put us at risk,” said Thomas Equels of Hemispherx. “We had to move quickly to ameliorate long-term damages and redirect resources, seeking to avoid a prolonged delay in the production of Alferon. While this situation has caused some disruptions and delays in our timeline, and has been challenging for a small pharmaceutical company like Hemispherx, I am happy to announce our direct contract with Gulf Coast Regional Blood Center as an important first step toward solving the problem caused by BioLife's egregious breach of contract. By obtaining direct contracts with different blood centers, we will restore the flow of leukocytes and reduce the risk that this problem will ever reoccur."
