Drug Delivery Leader

Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success. https://lnkd.in/dd5Vavq3 By Abigail Hisler, Strategic Marketing Director of Biologics, West Pharmaceutical Services

What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment from Drug Delivery Leader's live event, consultant Laurie Brager Auerbach underscores the criticality of management commitment to and engagement in the process. Watch the segment: https://lnkd.in/d-sEmeaY

In this second article of a planned series about bacterial endotoxin testing, Yadnyesh Patel shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test. https://lnkd.in/eBJntYyM Read part 1 here: https://lnkd.in/eQaVkYaf

Choosing the right container closure system (#CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential. Get a full understanding of CCS here: https://lnkd.in/e4nykf2d By Louis Brasten, West Pharmaceutical Services

What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment from Drug Delivery Leader's live event, consultant Laurie Brager Auerbach explains the relationship between the two guidance documents. Watch it here: https://lnkd.in/e6v_9aFb

By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices. https://lnkd.in/eRrTji_a By Jessica Sanford, Ph.D., Senior Human Factors Engineer, Battelle

Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits. https://lnkd.in/esjSsYBx By John Hoekman

All injectable drug products and implantable #medicaldevices that come into contact with the bloodstream or spinal fluid are tested for #endotoxins to ensure patient safety using bacterial endotoxin testing. In this new Drug Delivery Leader article, Yadnyesh Patel provides an overview and an introduction to the LAL method. https://lnkd.in/evfKvtXC #drugmanufacturing #pharmaceuticalmanufacturing

Explore how psychological principles can shape the design of medical device training and the significance of these principles in developing an effective training protocol for new medical device users. https://lnkd.in/eCMygJus By Taylor Hall, Human Factors Engineer, and Brianne Pragg, Ph.D., Human Factors Engineer, Battelle

By understanding the reasoning behind extractable & leachable testing, we can appreciate its role in protecting public health and enhancing customer trust. https://lnkd.in/ea3tmQWC By Todd J., West Pharmaceutical Services