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Unpacking The FDA Draft Guidance On Container Closure Systems
In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems.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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
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![04 West]( "Fixtures And Surrogates For Combination Product Performance Testing")
The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.
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![West]( "Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform")
Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.
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![West1]( "Early Decisions To De-Risk The Transition To Combination Products")
The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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![iStock-1256322438-lab-research-scientist]( "Nanosuspension Dosage Forms: Product Development & Scale Up")
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
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![1mL_long_wNeedleShields_Glam copy]( "De-Risk Your Combination Product Development")
Adopting a unified, pre-verified drug delivery system streamlines performance testing and data management, ensuring developers reach critical clinical milestones with greater speed.
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![iStock-635767756-clinical-trial-research]( "Formulation Development Strategy For Early Phase Human Studies")
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![StavanatoGroup-Vertiva On-Body Delivery System]( "Highly Flexible And Customizable On-Body Delivery System Platform")
Learn how Vertiva™ can enable delivery of micro-precision basal doses and full-content bolus injections, resulting in a highly flexible, customizable platform suitable for a wide range of therapies.
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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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![GettyImages-1133603364-lab-equipment-microscope-beaker-test tube]( "Formulations For Poorly Soluble And Low Bioavailability Drugs")
Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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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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![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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![West-DELIV 2 - GC_App_^CZ vial with stopper and seal stack up]( "Proven Vial Containment That Scales From R&D To Commercial")
Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.
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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-1268574717-food-inspect-ship-package]( "A/L/P Assembly, Label And Packaging")
Integrated device assembly, labeling, and packaging solutions streamline pharma delivery, ensuring compliance, scalability, and patient-centric design from clinical trials to commercial production.
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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.
