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 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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-1413607446-vial-syringe-liquid-scientist-glove]( "Preparing Global Parenteral Sites For Annex 1 Compliance")
Modern sterile manufacturing requires proactive quality risk management. Robust contamination control across facilities, processes, and supply chains supports compliance and patient safety.
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![BD Medical-1]( "Gliding Towards De-Risked Combination Product Development")
Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.
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![autoinjectables-clinical-GettyImages-2197657107]( "MIDBA: A New Regulatory Approach To Clinical Device Bridging")
When devices evolve, evidence expectations can shift. Explore a risk-based clinical bridging approach to support regulatory decisions.
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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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![Image 3]( "Protecting Your Drug Product: Integrating Engineering And Quality")
Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.
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![image2]( "How To Address Challenges In Oncology Drug Containment")
Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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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.
INJECTABLE DRUG DELIVERY SOLUTIONS
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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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![GettyImages-1327977869-lab-cell-biologic]( "Better Solutions For Your Drug Product")
With world-class facilities, the state-of-the-art equipment and some of the industry’s most talented people, you can feel confident that your small molecule drug product is in safe hands. Learning from decades working with other small molecules, INCOG has been purpose-built to provide better solutions for the global injectable drug product sector.
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![iStock-1214764688-scientist-lab-analyze-research]( "Analytical And Testing Services")
As part of Stevanato Group’s commitment to R&D, our analytical testing facilities focus on investigating physico-chemical properties of primary packaging materials and components and studying the interactions between container closure system and drugs. Stevanato Group relies on a multi-disciplinary team of highly skilled professionals, including, scientists, engineers, pharmaceutical chemists and biotechnologists. Their knowledge and experience covers a range of specialized areas including container closure systems and drug-delivery devices.
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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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![iStock-1057830102-gloves-lab-sample]( "Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials")
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.
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![GettyImages-2156834696-light-bulb-innovation-idea-creativity]( "Battelle: 90 Years Of Innovation")
Battelle, a leading nonprofit in applied science and technology, drives innovation in national security, healthcare, environment, and education while managing research labs and advancing critical discoveries.
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![West_GC_App_PFS 1 mL 1_3mL Plungers 003 WestPharm_2_1ml_1-3ml_Plungers LR]( "Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success")
From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.
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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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![FillFinish_450x300]( "Fill Finish Solution - Maximize Drug Product Recovery")
Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.
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![DD 1 - GCAPP_Valor size 2 Vial]( "The Future Of Glass Packaging Is Here")
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.
