INJECTABLE DRUG DELIVERY ARTICLES
Rethinking The Blueprint For Bone Regeneration: The Next Evolution In Orthobiologics
Next-generation orthobiologics could transform spinal fusion by enabling targeted bone regeneration, improving safety, and reducing reliance on traditional grafts and hardware.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![GettyImages-1371707479-lab-mask-team-partnership]( "Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products")
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
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![02 West]( "Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics")
All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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![West]( "USP <382>: Think Systems, Not Components")
This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.
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![USP_Article_Picture_2]( "A Smooth Transition To USP <382> With Established Expertise")
A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.
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![GettyImages-1388184871-quality-compliance-approval]( "From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation")
Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.
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![04 West]( "Delivering Market Success For Pharma Partners From Concept To Patient")
The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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![GettyImages-1413607446-vial-syringe-liquid-scientist-glove]( "What To Consider When Looking For A CDMO In Drug Substance Utilization")
Optimize drug substance use during fill/finish. Learn how advanced line configurations and 100% non-destructive weight checks mitigate process drift, protect therapeutics, and prevent product loss.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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![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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![Medical Research-GettyImages-2162956896]( "Medical Device Solutions Fact Sheet")
Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Pre-Filled Precision In Every Dose")
More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.
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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
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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.
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![GettyImages-2176475661 tabet press, pharma manufacturing]( "Streamlining The Generic Combination Device Design Assessment Process")
A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.
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![Medical professional filling out paperwork-GettyImages-1132204239]( "Bridgeton – Our World Class Fill Finish Facility")
A scalable aseptic environment for diverse injectables, advanced automation, and Annex 1–aligned processes, supporting smooth transitions from development to commercial supply and long‑term strategy.
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![GettyImages-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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![VFM]( "Pharmaceutical Vial Filling Equipment: VFM")
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
