Injectable Drug Delivery Resources

31. De-Risking Visible Particles Through Component Selection

    Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

32. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

33. Formulation Research Strategy For Discovery- Stage New Drug Candidates 1/24/2022

    Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

34. 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.

35. Stopper Functionality – Key Considerations

    When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.

36. Characterizing The E&L Profile Of Stoppers For Drug Stability 6/11/2024

    The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

37. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

38. Annex 1 Revisions - What You Should Know 3/10/2023

    Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

39. Self-Injection Of Biologics Made Easy 6/17/2022

    Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

40. Design Verification Testing Of Combination Products 7/12/2024

    Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.