Injectable Drug Delivery Resources

31. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

32. Overcoming Challenges In Cell And Gene Therapy Containment

    Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

33. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

34. Collaborating With A CMO To Bring Your Sterile Injectable Product To Market 2/15/2023

    Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.

35. Decoding the FDA Guidance on Essential Drug Delivery Outputs 2/18/2025

    The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

36. Key Trends And Developments In Injectable Drug Formulation And Delivery

    As the biopharmaceutical market continues to grow, explore the barriers facing manufacturers and how to best evaluate a drug substance's characteristics and determine the most appropriate delivery device.

37. De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions: BD Physioject™ Disposable Autoinjector For Tirzepatide 6/26/2025

    BD Physioject™ for Tirzepatide supports FDA ANDA submissions with proven usability, low error rates, and a design validated to match the reference listed autoinjector.

38. Packaging And Containment: Get Your Products To Market Faster

    Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.

39. Streamlining The Path To Market For Generic Drug-Device Combinations 9/18/2024

    Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.

40. Container Closure Integrity Evaluation For Cell And Gene Therapies

    With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.