FDA Takes Enforcement Action Regarding Genzyme's Allston Plant
The US Food and Drug Administration has notified Genzyme Corporation (Cambridge, MA) that it intends to take enforcement action to ensure that products manufactured at its Allston, MA, plant are made in compliance with good manufacturing practice regulations.
The US Food and Drug Administration has notified Genzyme Corporation (Cambridge, MA) that it intends to take enforcement action to ensure that products manufactured at its Allston, MA, plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely result in a consent decree, under which a third party would inspect and review the plant's operation for an extended period and certify compliance with FDA regulations. Under the consent decree, Genzyme also would be required to make payments to the government and could incur other costs.
Based on its initial communication with the agency and the medical need for patients, Genzyme expects that shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), which are manufactured in Allston, will continue uninterrupted during the period of the enforcement action. In addition, Genzyme expects that shipments of Myozyme (alglucosidase alfa) produced at the 160-L scale, which is filled and finished in Allston, will continue uninterrupted. The discussions with the FDA are expected to occur over the next several weeks.
Previous coverageFDA Approves Shire's New Gaucher Drug
Shire Files Marketing Applications for Fabry and Gaucher Disease Drugs
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
