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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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-517743436-plasmid-dna-development-lab]( "Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery")
Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.
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![OP 1 - GCAPP_20mm Seal-Stopper_Vial Size 10_Valor-V2 (2) - Copy]( "Improve Speed To Market By Mitigating Vial And Stopper Incompatibility")
These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.
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![1mL_Standard_Laying_Down copy]( "Selecting A Prefillable Syringe System With Confidence")
Prefilled syringe selection can stall drug development for months. This system integrates barrel, plunger, and needle shield from a single supplier, reducing complexity for emerging biotech.
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![730A2291_1ST PASS]( "A Clear Path From Feasibility To Regulatory Submission")
This step-by-step flow helps guide teams from early feasibility assessments all the way through to regulatory submission, with greater clarity at each stage.
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![GettyImages-1426756188-scientists-in-lab-with-computer-analyzing]( "A Strategic Guide For Challenging Early-Phase Molecules")
Early formulation decisions for high-viscosity, unstable, and potent molecules impact scale-up, regulatory flexibility, and lifecycle value. Getting them right early helps avoid costly rework.
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![PO 1 - 3e FunShot_4]( "Experimental And Theoretical Evaluation Of Vial Container Closure System Components")
Review the comparison of two container closure systems which differ by stopper hardness using comprehensive stack-up calculations performed by West’s DeltaCube™ Modeling Platform.
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![INCOG]( "Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing")
This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![GettyImages-1327623919-lab]( "Drug Product Services: Pre-Formulation To Commercial-Scale Production")
Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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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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![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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![Stevanato]( "Automated Vision Inspection Systems For Injectable Drug Products: Vials, Syringes, Cartridges, Bottles")
We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.
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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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![denesting]( "Pharmaceutical De-Nesting Equipment For Syringes And Cartridges")
The DNS machines are designed for de-nesting pharmaceutical syringes and cartridges in nest without damaging them. Thanks to their precision, you can reach a higher speed and automatically connect the filling machine with the final production system. DNS machines are characterized by: Robotized precise handling of pharmaceutical syringes/cartridges, Automated tub and nest handling, Convenient operation with touch screen, and Secure and efficient recipe management.
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![I01_Labs 173_WestPharm_Direct 113018-143]( "Don't Just Launch Your Molecule, Protect It!")
Accelerate your path to market with integrated support to streamline processes, reduce delays, and deliver safe, user-friendly drug-delivery solutions.
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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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![Medical Research-GettyImages-2162956896]( "Medical Device Solutions Fact Sheet")
Battelle provides end-to-end medical device development services, combining engineering, regulatory, and human-centric design to accelerate innovation from concept through commercialization across diverse therapeutic areas.
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![Getty Images-1087219418-fill-filling]( "Pharma Services Fill, Finish & Drug Delivery CDMO")
Sterile fill-finish and device assembly capabilities span global sites, offering scalable solutions, analytical testing, and regulatory compliance for combination products and small-batch technical programs.
