FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues, and Cellular and Tissue-Based Products
FDA ordered Donor Referral Services (Raleigh, NC) and its owner, Philip Guyett, to immediately cease all manufacturing operations and to retain human cells, tissues, and cellular- and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.
FDA ordered Donor Referral Services (Raleigh, NC) and its owner, Philip Guyett, to immediately cease all manufacturing operations and to retain human cells, tissues, and cellular- and tissue-based products (HCT/Ps) after an inspection found serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping. The regulations require firms to properly screen and test donors. This action was taken under FDA’s new tissue regulations, which took effect on May 25, 2005 and which allow the agency to take swift action if needed to protect the public health. For more information, see: www.fda.gov/cber/compl/drs081806.htm
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.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
