INJECTABLE DRUG DELIVERY ARTICLES
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-1346675584-team-lab-research-development]( "Key Considerations For Emerging Companies When Selecting Packaging Components")
Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.
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![GettyImages-1322057206-self-injection-device-delivery]( "De-Risking The Transition From Vial To Drug-Device Combination Product")
When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.
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![GettyImages-1285108730-syringe-self-injection-treatment]( "Self-Injection Of Biologics Made Easy")
Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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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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![BD_Physioject_IMG_1404-450x300]( "De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions")
Discover an autoinjector platform that supports ANDA pathways with demonstrated usability and design alignment to help development teams reduce risk and move confidently toward regulatory submission.
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![GettyImages-1191463139-lab-test-tube-experiment]( "Steps To Overcome Challenges Associated With Biologic Formulation Development")
Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).
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![Scientists Mixing Solution In Lab GettyImages-1443286944]( "Formulation Development For Injectables")
A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![GettyImages-1171312168-lab-development-research]( "A CDMO With Oral Solid Dose And Sterile Injectable Expertise")
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
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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-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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![VFM]( "Pharmaceutical Vial Filling Equipment: VFM")
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "BD Neopak™ XtraFlow™ Glass Prefillable Syringe")
A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.
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![BD]( "Easy-To-Use 1 mL Disposable Autoinjector")
BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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![West-SBO 2 - GCApp_Instron]( "Freeze Your Device Design With An Integrated, Verified PFA System")
Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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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.
