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A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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

  • 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.

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

  • 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.

  • Analyze a family of fill/finish solutions that offers a complete, configurable solution for biopharmas and CDMOs looking to maximize drug product recovery.

  • 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.

  • A scalable aseptic environment for diverse injectables, advanced automation, and Annex 1–aligned processes, supporting smooth transitions from development to commercial supply and long‑term strategy.

  • Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.

  • 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.

  • ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.

  • Capabilities that improve efficiency and accelerate development.

    B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.