Yadnyesh Patel continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (#MVD), including those for active substances and excipients, combination products, and medical devices. https://lnkd.in/ewwSrb9Z
Drug Delivery Leader
Internet Publishing
Cranberry Township, Pennsylvania 1,295 followers
Valuable insights, discussions, and resources for professionals working in drug delivery.
About us
Drug Delivery Leader focuses on the people, technologies, and processes responsible for optimizing the therapeutic delivery of pharmaceutical compounds. The community highlights best practices and advancements throughout the development process with respect to drug delivery, from drug formulation to the design/development and, ultimately, procurement of drug delivery solutions. Scientific and engineering professionals will gain insights into addressing the biggest challenges related to drug delivery – via injectable, oral solid dose, inhalation, infusion, transdermal, and ocular routes of administration.
- Website
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https://www.drugdeliveryleader.com/
External link for Drug Delivery Leader
- Industry
- Internet Publishing
- Company size
- 51-200 employees
- Headquarters
- Cranberry Township, Pennsylvania
- Specialties
- life sciences and drug delivery
Updates
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A proactive approach to packaging development can ultimately ensure a smoother launch. Explore 5 key considerations in selection components for your injectable drug product: https://lnkd.in/eKF6kGUg By Abigail Hisler, Strategic Marketing Director, Biologics, West Pharmaceutical Services
The Importance Of Selecting Packaging Components: A Practical Checklist For Emerging Biotechs
drugdeliveryleader.com
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What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment from Drug Delivery Leader Live, consultant Edwin Bills, ASQ Fellow, RAC discusses when and how organizations will now need to address risk management within the context of design development and controls: https://lnkd.in/e_2GyQV9
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Regulatory guidance and standards, in official documentation, tend to emerge at a slower pace than do industry best practices. In Part1 of a two-part series, Fran DeGrazio explains why biopharma companies should build and apply best practices in advance of official regulations regarding drug product quality. https://lnkd.in/eFc57F9d
Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
drugdeliveryleader.com
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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
Simplify Your Move From A Vial To A Prefilled Syringe: Lifecycle Planning For Containment And Delivery Of Biologics Drug Products
drugdeliveryleader.com
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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
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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
Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
drugdeliveryleader.com
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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
Sealed For Safety: Understanding Injectable Drug Container Closure Systems
drugdeliveryleader.com
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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
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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
Overcoming Wet Injection Challenges With Human-Centric Design
drugdeliveryleader.com