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.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.