INJECTABLE DRUG DELIVERY ARTICLES
Reassessing Nanoparticle Immunotoxicity: From Well-Established To Novel Approaches
This article highlights government-funded resources available to de-risk nanomedicines, reviews principles of immunotoxicity testing, and discusses emerging methodologies.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![Epigenetic therapies of the future_GettyImages-2203738408]( "Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.")
By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.
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![GettyImages-1057026794-lab-sterilization]( "4031 Ready Methods Reduce E&L Timelines")
An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.
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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-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![Patent Trolls]( "The Largest LOE Event In US Pharma History")
Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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![Self injection med device GettyImages-1322057207]( "Overcoming Wet Injection Challenges With Human-Centric Design")
By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.
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![GettyImages-627023398 clinical lab]( "Navigating PFAS \"Forever Chemicals\" In Medical Devices - What's On The Horizon")
Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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![GettyImages-1964958878 glucose monitor wearables patient doctor]( "Putting More Within Reach")
A wearable subcutaneous injector is being developed to support delivery of large‑volume, complex biologic therapies, expanding options for patients needing advanced at‑home administration.
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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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![GettyImages-1392016982 business meeting]( "Medical Device Technical Due Diligence")
By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.
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![chemistry-tech-center-GettyImages-1417397137]( "Battelle's Chemistry Technical Center (CTC)")
Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.
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![GettyImages-1938951579-automation-filling-bottles-modern-robot-manufacturing]( "Aseptic Fill Finish")
One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
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![GettyImages-1327623919-lab]( "Drug Product Services: Pre-Formulation To Commercial-Scale Production")
Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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![Singota-aseptic]( "Aseptic Manufacturing Services")
Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.
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![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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![ASEPTiCell]( "Isolator Barrier Pharmaceutical Aseptic Filling Systems")
ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.
