INJECTABLE DRUG DELIVERY ARTICLES

GettyImages-1347460948edited Navigating Combination Products: Device Complexity And Software Integration

Software-enabled combination products demand early cross-functional alignment, regulatory foresight, and collaboration to avoid delays and accelerate patient access.

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A review of the draft guidance and importance of component selection as it relates to establishing a risk-based approach and the role of the NovaPure product line in component selection.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

  • 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.

  • 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.

  • Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable, powered by Pfizer’s global network of experts, reliability, and flexibility.

  • Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

  • 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.

  • We are the exclusive manufacturing partner for this innovative auto-injector platform.

  • 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.

  • BD Physioject™ Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • 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.