FDA Approves Biologic to Treat Common Bleeding Disorder
The FDA has approved Humate-P (antihemophilic Factor/von Willebrand Factor Complex), CSL Behring's (Marburg, Germany, www.cslbehring.com) factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD).
The FDA has approved Humate-P (antihemophilic Factor/von Willebrand Factor Complex), CSL Behring’s (Marburg, Germany, www.cslbehring.com) factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD). Humate-P will be used for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe VWD.
The new indication approval follows the results of two separate clinical studies-one in Europe, another in the United States. The product was originally approved in 1999 for use in adult patients to treat and prevent bleeding from hemophilia A. It was later approved to treat spontaneous and traumatic bleeding for severe VWD and for mild and moderate VWD when desmopressin use is known or suspected to be inadequate.
Humate-P works by replacing von Willebrand factor/factor VIII that is missing in patients with VWD. Humate-P is made by purifying the needed clotting protein from human plasma from carefully screened and tested US donors. The distribution of high molecular weight multimers in Humate-P corresponds closely to that found in normal human plasma.
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.
