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.
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.
Biophysical and Aggregate Characterization for the Development of Biologics
June 10th 2025This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.
Psilera, Hesperos Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
