In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.
The Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy
April 28th 2025Forced degradation studies are critical in biologics development, particularly for monoclonal antibodies (mAbs). These studies simulate long-term environmental stressors to uncover degradation pathways and ensure the stability of critical quality attributes (CQAs), aiding in robust chemistry, manufacturing, and controls (CMC) strategies and regulatory compliance.
3D Screen Printing: Enabling A New Generation of Complex Formulations
April 14th 20253D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.
ROSS Ribbon Blenders - Video in Action
March 26th 2025ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.