In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
- Trans-Arterial Micro-Perfusion For Improved Drug Delivery
- Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm
- The Key to Regulatory Innovation? Global Harmonization
- Balancing Sustainability With Patient Safety In Medical Device Design
- EMA Updates Guidance On Inhalation And Nasal Product Quality
- Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
- A Holistic Approach To Container Closure Integrity
- New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
ON-DEMAND WEBINARS
Explore an overview of the regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.
We discuss three enabling technologies designed to improve drug solubility in organic solvents for spray drying and define the advantages and risks of each technology.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1335417630-vial-vaccine]( "Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems")
Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial SystemsReview the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.
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![Better Development And Formulation Solutions For Challenging Compounds Using Softgel Innovation]( "Solutions For Challenging Compounds Using Softgel Innovation")
Solutions For Challenging Compounds Using Softgel InnovationThe significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
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![West Pharma - Article 4 - ALS EandL Tile and banner]( "Plan For Your Extractables And Leachables Studies To Meet Submission Timelines")
Plan For Your Extractables And Leachables Studies To Meet Submission TimelinesDemonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "How Recent Trends Impact Bringing Your Molecule To Market")
How Recent Trends Impact Bringing Your Molecule To MarketWith accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
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![Scientists In Lab GettyImages-1354171846]( "A Smarter Strategy For Optimizing Oncology Drug Products")
A Smarter Strategy For Optimizing Oncology Drug ProductsJohn McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.
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![West Pharma - Article 2 - ELAS LYO Lyotec-012 LREZ]( "Have You Selected The Right Stopper For Your Lyophilized Drug Product?")
Have You Selected The Right Stopper For Your Lyophilized Drug Product?Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.
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![GettyImages-1253545551-OSD-pill-tablet-oral-solid-dose]( "A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients")
A Taste Masked And Easily Swallowed Malaria Drug For Elderly PatientsDysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how microencapsulation enabled formulation of a water-soluble powder drives patient adherence.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
10 Ways To Align Your Medical Device With Human Factors Industry Best PracticesDiscover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage")
Overcoming The Challenge Of Maintaining Sterility At Low Temperature StorageLearn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.
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![Vials pharma manufacturing GettyImages-618518692]( "Key Considerations For Selecting Fill/Finish Manufacturing Technologies")
Key Considerations For Selecting Fill/Finish Manufacturing TechnologiesObtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
Tom ensures that Drug Delivery Leader provides you with indispensable resources for staying current on the industry’s most innovative thinking. Get in touch today!
In her new column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "Embrace Packaging and Delivery Systems Designed for Today's Standards")
Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
