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 RESOURCES
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Wurster processing is a versatile pharmaceutical development and manufacturing technique for multiparticulates in modified release dosage forms. Understand if it's the right method for your modified-release project.
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Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.
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Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.
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A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.
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The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.
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Choosing a wearable delivery platform goes beyond technical fit. Discover how performance, patient experience, development readiness, and lifecycle planning shape long-term success.
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The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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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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A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.
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BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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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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We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.
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Advanced nanotechnology improves biologics with higher drug loads, better stability, new delivery routes, and enhanced performance in injectables, inhalation, and long‑acting therapies.
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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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The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
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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.