INJECTABLE DRUG DELIVERY ARTICLES
Navigating Combination Products: Device Complexity And Software Integration
Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![West]( "Streamlining Primary Container And Device Selection With Predictive Calculations")
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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![Vials pharma manufacturing GettyImages-618518692]( "Comparing Vial Container Closure Systems")
Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.
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![stevanatogroup_light_obscuration]( "Container Selection For A Highly Sensitive Drug Product: A Success Story")
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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![West-MDO 2 - GC_APP_Photoshoot 2021 Single Vials Glamour V8]( "How Recent Trends Impact Bringing Your Molecule To Market")
With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
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![Syringes GettyImages-171324030]( "Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation")
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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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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![Stevanato]( "Overcoming A Failed Design Verification Test For Your Delivery Device")
If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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-1426756188-scientists-in-lab-with-computer-analyzing]( "Improve The Performance Of Your Biologic Formulations")
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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![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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![West-C&G 3 - 2mL_10mL_Vials_Tubs]( "Daikyo Crystal Zenith® Ready-To-Use Nested Vials")
West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.
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![Capture]( "Injection Molding")
Capabilities that improve efficiency and accelerate development.
B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.
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![ASEPTiCell ScreenShot 1]( "Robotic Multi-Format Filling & Closing System")
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
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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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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Transforming Drug Delivery")
Learn how our team of scientists, engineers, and human-centered designers, as well as our world-class facilities, empower us to confidently guide your product toward a successful market launch.
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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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![Lipid Nanoparticles GettyImages-1437855772]( "Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles")
Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.
