INJECTABLE DRUG DELIVERY ARTICLES
6 Packaging And Delivery Challenges For Biologic Therapies
In this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-1311518492-vaccine-vial]( "A Glass Package Designed Specifically for Pharmaceutical Use")
A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.
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![GettyImages-1002000796-lab-research-scientist-development]( "Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials")
The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.
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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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![West_CZ Insert Needle 115860aw 11569_RGB_2]( "A Practical Packaging Components Checklist For Emerging Biotechs")
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
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![GettyImages-1306440102-sterile-injectable-syringe]( "The Growth Of Sterile Injectables")
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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![Singota]( "Faster From Formulation To Fill/Finish")
Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.
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![Vials pharma manufacturing GettyImages-618518692]( "The Parenteral Drug Delivery Market")
Gain insight into the significant trends impacting the aseptic industry. This report focuses on key parenteral areas of aseptic manufacturing, scale-up, primary packaging options, and targeted treatments.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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![VFM]( "Pharmaceutical Vial Filling Equipment: VFM")
VFM automatic filling and stoppering machines are designed for injectable solutions in vials.
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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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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![iStock-493302504-scientist-lab-development]( "Pre-Formulation And Material Sciences")
Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.
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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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![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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![Automated Sys Of Tacome Product]( "Pharmaceutical Aseptic Filling Equipment")
AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
