Injectable Drug Delivery Resources

51. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

52. Using 505(B)(2) To Streamline Approval Of Combination Products 2/2/2023

    In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

53. Key Considerations When Filling Dual Chamber Syringes 11/22/2022

    Dual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.

54. A Lifecycle Management Strategy For Sterile Injectables 12/9/2022

    Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

55. 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.

56. 4031 Ready Methods Reduce E&L Timelines

    An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

57. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

58. New Technologies To Improve Solubility Of Brick Dust Compounds 7/13/2022

    David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

59. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

    As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

60. Spray Drying For Improved Solubility 11/15/2022

    Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.