INJECTABLE DRUG DELIVERY ARTICLES
Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![GCAPP_High Class Research Microscope-381_WEST]( "Why Lower Endotoxin Levels Matter: Raising The Bar For Patient Safety And Product Quality")
Strengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products.
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![DD 2 - 2mL_10mL_Vials_Tubs_Capped]( "Safeguarding Cell Therapy Cryopreservation: Primary Containers")
Review different aspects of container selection from the perspective of cryopreservation that are may be overlooked but critical for the quality of cell therapy drug products.
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![iStock-1319077865-lab-team-computer-research]( "Selecting Drug Delivery Systems For Higher Doses, Viscosities And Lower Risk")
Discover how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.
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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.
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![GettyImages-525440891-lab-research-development]( "Avoiding The Pitfalls Of LNPs And Complex Formulations")
Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.
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![GettyImages-1218520471-development-research-lab-PPE]( "Factors To Consider When Selecting A CDMO For Complex Injectables Development And Manufacture")
The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities and operations to adopt GMP practices with a "laboratory setting."
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![23_03_PO_Annex1_450x300]( "Annex 1 Revisions - What You Should Know")
Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![Medical professional filling out paperwork-GettyImages-1132204239]( "Bridgeton – Our World Class Fill Finish Facility")
A scalable aseptic environment for diverse injectables, advanced automation, and Annex 1–aligned processes, supporting smooth transitions from development to commercial supply and long‑term strategy.
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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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![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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![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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![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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![cmo-cdmo-drug-discovery-GettyImages-184944030 (1)]( "Meet The Demands Of Today To Help Ensure The Possibility Of Tomorrow")
Emergency‑readiness programs strengthen response with dependable countermeasures, rapid‑action tools, and decades of expertise supporting teams facing chemical, biological, and other high‑risk threats.
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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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![GettyImages-1938951579-automation-filling-bottles-modern-robot-manufacturing]( "Aseptic Fill Finish")
One of the few CDMOs offering sterile fill, device manufacturing, and final assembly at one site — combining expertise, scale, and flexibility for clinical, commercial, and niche production.
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![BD]( "Easy-To-Use 1 mL Disposable Autoinjector")
BD Physioject™ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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![West-PFS SYRG-0178 NovaPure]( "An Integrated, Verified PFS System For Vaccines")
A pre-verified delivery platform eliminates redundant testing, simplifies regulatory submissions, and optimizes inventory management, allowing teams to focus on drug-specific performance.
