Webinar: Testing of the packaging: Extractable study design and challenges
Large volume parenteral applications are characterized by high volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. Definitions and regulatory requirements for extractables and leachables testing of large volume parenteral products, will be highlighted. Next, typical sources of extractables and leachables in flexible bag systems for parenteral use will be listed. Emphasis will be put on the specific challenges associated with large volume parenteral applications. Finally, some case studies regarding different designs of extractable studies will be discussed.
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.
