The Food and Drug Administration has approved the final phase of efforts by UMass Medical School’s MassBiologics to modernize its vaccine manufacturing operations and move its tetanus and diphtheria vaccine production completely to Mattapan facilities.
“This significant milestone represents the culmination of nearly two decades of teamwork to upgrade and migrate a complex, multipart manufacturing process into state-of–the-art, purpose-built facilities, thus ensuring for another generation the ongoing public health mission of MassBiologics, which remains the only non-profit FDA licensed biologics manufacturer in the nation,” said Mark S. Klempner, MD, executive vice chancellor of MassBiologics.
MassBiologics has produced biologic medicine since 1894 and has been continuously licensed by the federal government to distribute them in the United States for 98 years. For nearly all of its history, the organization has manufactured the important medicine at its original location in Jamaica Plain. Throughout the decades, it has become increasingly stringent to produce drugs for the use in human patients and it became clear that there was a need to modernize the MassBiologics facilities to adhere to those standards. In 1997 when MassBiologics became part of the UMass Medical School system, the decision was made to create a new campus in Mattapan, with ground breaking on the new facility in 2003.
Gradually, certain aspects of the vaccination manufacturing process were relocated to Mattapan. The organization’s final goal was achieved on Dec. 3 when the FDA issued its approval for the Td product that was made with all biologics produced, filled, inspected and packaged in Mattapan.
“MassBiologics takes great pride in its research, discovery, process development and commercial contract manufacturing of licensed and investigational biologic medicines. And those activities remain key components of MassBiologics’ identity,” Dr. Klempner said. “What makes us unique is the ultimate ability to deliver medicines from FDA approved facilities and that capability is built on the efforts and discipline required to support the manufacture of MassBiologics own product.”