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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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

INJECTABLE DRUG DELIVERY SOLUTIONS

  • VFM automatic filling and stoppering machines are designed for injectable solutions in vials.

  • An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.

  • Syngene's Sterile Fill-Finish facility is custom-built to meet market demand for clinical supplies, sterile drug products having short development timelines,

  • 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.

  • 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.

  • Leverage a pre-verified, integrated syringe platform. Accelerate timelines and reduce costs by eliminating drug-independent testing while streamlining regulatory submissions through one source.

  • As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

  • As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.

  • 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.

  • 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.