INJECTABLE DRUG DELIVERY ARTICLES
Antibody–Oligonucleotide Conjugates, Part 4: Regulatory Considerations And Future Directions
This last article of the author's series on AOCs reveals regulatory perspective, analytical opportunities, the emergence of molecular quality by design, and the CMC challenges to address with future work.
INJECTABLE DRUG DELIVERY VIDEOS
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Explore the challenges related to packaging of cell and gene therapy products and proven solutions to enable speed to market and compatibility, performance of packaging materials.
Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.
A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.
INJECTABLE DRUG DELIVERY RESOURCES
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![West1]( "Early Decisions To De-Risk The Transition To Combination Products")
The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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![West-NovaPure]( "Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems")
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Characterizing The E&L Profile Of Stoppers For Drug Stability")
The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.
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![GettyImages-949946968-lab-research]( "A Risk-Based Approach To Injectable Combination Product Development")
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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![sterile-injection-capsules]( "Collaborating With A CMO To Bring Your Sterile Injectable Product To Market")
Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.
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![1mL_Standard_Laying_Down copy]( "USP <788> Revisions And Why Packaging Matters More Than Ever")
Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![West_GC_App_PFS 1 mL 1_3mL Plungers 003 WestPharm_2_1ml_1-3ml_Plungers LR]( "Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success")
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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![DD 1 - GCAPP_Valor size 2 Vial]( "The Future Of Glass Packaging Is Here")
Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.
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![GettyImages-2156834696-light-bulb-innovation-idea-creativity]( "Battelle: 90 Years Of Innovation")
Battelle, a leading nonprofit in applied science and technology, drives innovation in national security, healthcare, environment, and education while managing research labs and advancing critical discoveries.
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![BD-xtraflow-]( "Glass Prefillable Syringe Solution Delivering Complex Biologics")
BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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![ypsoflow]( "Smart Connected Selfcare For The Prefilled YpsoFlow Pen")
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![GettyImages-2166352840-scientists-in-lab-with-computer-screen]( "Analytical Services: Solutions For Every Testing Need")
Integrated analytical testing keeps method development, release, and stability data aligned with manufacturing for potent, cytotoxic, and controlled-substance products across all phases.
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![GettyImages-1600719545 lab]( "Innovative Formulations And Higher Drug Loads Across The Life-Cycle")
Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.
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![West-DELIV 2 - GC_App_^CZ vial with stopper and seal stack up]( "Proven Vial Containment That Scales From R&D To Commercial")
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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![Pharma-Aseptic]( "Pharmaceutical Aseptic Filling Systems For Sterile Injectables")
The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.
