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
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.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
