FDA Approves Second-Generation Smallpox Vaccine From Acambis
The US Food and Drug Administration (FDA) has approved the ACAM2000 vaccine made by Acambis (Cambridge, UK, www.acambis.com), for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
The US Food and Drug Administration (FDA) has approved the ACAM2000 vaccine made by Acambis (Cambridge, UK, www.acambis.com), for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. This approval is a key step towards Acambis’ finalizing a long-term manufacturing contract with the US Government. Acambis developed the vaccine under contracts with the US Centers for Disease Control and Prevention (CDC) as part of its preparations for a public health emergency. ACAM2000, which is a single-dose vaccine, is the primary smallpox vaccine for use in an emergency and forms the majority of the US Government's smallpox vaccine Strategic National Stockpile. Acambis has supplied 192.5 million doses of ACAM2000 to the CDC for the stockpile.
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.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
