Spectrum Chemical: The Right Ingredients Backed by Quality Control
Fast Pharma: Balancing Risk and Quality with Time to Market
The complex journey of pharmaceutical discovery and development ideally leads to successful product commercialization that will address patients’ medicinal needs worldwide, but the path from discovery to launch often requires a careful calculation involving risk and the standardization of quality in a global environment. This article will discuss some of the top challenges facing drug developers and how R&D scientists and procurement specialists are working together to bring new products to market faster while ensuring quality.
The new Drug and Supply Chain Security Act (DSCSA) and other regulations are intended to keep small-molecule and biologic drugs safe in an increasingly fragmented pharmaceutical ecosystem. The complexity of a globalized chemical industry, in which chemicals and reagents used to make a drug may originate in multiple countries, enhances efficiencies but can also increase risks, and regulations may differ from country to country. This ebook will highlight the coming changes in regulations that apply to drug manufacturers, the need for and application of these regulations in both the small-molecule and biologic drug arenas, and the challenges of maintaining a robust, safe drug supply chain.
Meet increasing quality, safety and regulatory requirements with confidence with Spectrum Chemical's bioCERTIFIED™ Quality Management System and products for biopharmaceutical manufacturing. Featuring expanded laboratory testing, certifications and scientific documentation, our bioCERTIFIED portfolio is tailored to each customer’s unique requirements from biopharmaceutical drug discovery to pilot and scale-up to production.
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.
