Getting Ready for Risk-Based GMPs
by Patrick Clinton, BioPharm International As FDA moves toward a new vision of GMP regulations, BioPharm International asked industry experts some key quextions: What form will risk-based GMPs take? What are the benefits and costs for biotech? Will the change really encourage innovation? And, most important, can FDA leaders get field inspectors to buy into the new approach?
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.
Personalized CRISPR Therapy Successfully Treats Infant With Rare, Incurable CPS1 Deficiency
May 16th 2025A pediatric patient with a rare genetic disorder safely received a personalized CRISPR therapy, marking the first known case of a personalized CRISPR-based medicine administered to a single patient.
