INJECTABLE DRUG DELIVERY ARTICLES
4 Delivery Science Lessons For RNA Developers
Drawing on published science, current guidance, and the author's own perspective, four delivery science lessons become clear for RNA developers.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-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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![Doctor Preparing Injection Site GettyImages-1379313214]( "Enabling Subcutaneous Delivery For Improved Patient Compliance")
The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.
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![GettyImages-1441771695-partnership-office-laptop-windows]( "8 Must- Haves When Choosing A CDMO Partner For Drug Development")
Complex programs raise the stakes of outsourcing. Eight criteria, each paired with questions to ask and signals to watch for, separate a true development partner from a vendor.
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![GettyImages-1325865279-patient-doctor]( "The Importance Of A Human Centered Approach To Product Development")
To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.
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![Expanding Subcutaneous Design Brick By Brick: The BD Neopak™ Glass Prefillable Syringe Platform]( "Expanding Subcutaneous Design Brick By Brick")
Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.
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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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![West-vials]( "Low Temperature Storage Containment For Vial And Syringe Systems")
With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![West-1]( "Simplify The Journey With A Combination Product Solution")
Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.
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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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![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.
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![BIMI]( "Aseptic Filling System For Pharmaceuticals: BI-MI")
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
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![I01_Labs 173_WestPharm_Direct 113018-143]( "Don't Just Launch Your Molecule, Protect It!")
Accelerate your path to market with integrated support to streamline processes, reduce delays, and deliver safe, user-friendly drug-delivery solutions.
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![BD]( "Enabling The Delivery Of Complex Biologics With Ergonomic Solutions")
The BD UltraSafe Plus™ passive needle guard for pre-filled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.
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![A-MICRO BI]( "Pharmaceutical Vial Filling Machine With Isolator")
Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.
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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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![iStock-1087219366-fill]( "Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials Of Insoluble Drugs")
Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.
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![LSC 09.26 Newsletter Ypsomed Fig 1]( "Connected Solutions For Self-Injection")
From enabling connected clinical trials to supporting digital therapy management, our solutions help improve clinical trial operational efficiency and data quality, strengthen commercial success, and empower patients to self-manage their therapy.
