INJECTABLE DRUG DELIVERY ARTICLES
Regulating For Patient Safety And Success With Combination Products
At the AFDO/RAPS Combination Products Summit 2025, a notable focus emerged around approaches to risk assessment and human factors studies. In this article, Chief Editor Tom von Gunden offers his appreciation for the biopharma industry’s consideration of patient usability and safety in the development and regulation of combination products and other drug delivery devices.
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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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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![SMC Image]( "'Smart Devices' vs. 'Smart Design' In User-Centric Autoinjector Design")
Oval Medical has developed a novel Prefilled Primary Drug Container that resolves many drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies.
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![GettyImages-1066989062-gene-cell-doctor-research]( "Vial Adapter Transfer Device Compatibility With Cell Therapies")
Needles and syringes are commonly used to retrieve cell therapies from vials, posing the risk of needle stick injury. Explore the suitability of needle-free polycarbonate transfer devices.
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![iStock-952307842-cryopreservation]( "T Cell Cryopreservation: Comparing Rigid Polymer Vials And Flexible Bags")
This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.
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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-995087800-lab]( "Drug Formulation Development: Quick Reference Guide")
This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.
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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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![GettyImages-542935478-lab-development-research]( "A New Mindset For Combination Product Development")
As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.
INJECTABLE DRUG DELIVERY SOLUTIONS
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![GettyImages-1279969622-self-injector-injection]( "The Intersection Of Material Science And Medical Device Design")
Learn how leveraging our expertise in fundamental materials science and applied engineering can help you not only avoid failures but also resolve them swiftly through our Rapid Response process.
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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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![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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![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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![ASEPTiCell ScreenShot 1]( "Robotic Multi-Format Filling & Closing System")
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
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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-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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![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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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
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![ASEPTiCell ScreenShot 3]( "Aseptic Filling Systems For Biopharmaceutical Manufacturing")
AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.
