INJECTABLE DRUG DELIVERY ARTICLES

Medicine bottles, tablets-GettyImages-120683161 Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.

  • Developing combination products requires navigating complex regulations. A solution that combines packaging, delivery systems, and expert support can accelerate your path to market and reduce risk.

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

  • 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.

  • Our formulation development and material sciences experts have over 30 years’ experience in pre-formulation and solid state characterization.

  • 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.

  • 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.

  • 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.

  • 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.