Articles

51. How To Ensure Correct Component Selection When Outsourcing To A CMO 3/22/2023

    A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

52. A Risk-Based Approach To Injectable Combination Product Development 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

53. Bag Flling Is Now Possible In The United States 2/10/2023

    Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).

54. Patient-Centric Oral Solid Dose Formulation 5/17/2022

    Gain insight into the systematic application of patient centricity to the design of OSD products.

55. Lyophilization And Sterile Manufacturing 5/5/2022

    The addition of global Sterile Fill-Finish and extensive lyophilization capabilities ensures that we are able to build on our enviable reputation and deliver on our promise of delivering life-changing therapies to patients worldwide.

56. Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials 1/28/2022

    Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.

57. Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials Of Insoluble Drugs 1/28/2022

    Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.

58. BD Libertas Wearable Injector 11/8/2021

    BD Libertas™ Wearable Injector is designed to deliver subcutaneous injections of large volume (2-5 mL or 5-10 mL) and/or high viscosity (up to 50 cP) fixed dose biologics for the non-acute setting.

59. Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS 10/12/2021

    Outlined here are the inherent benefits of PFS and how they relate to the delivery of drugs, such as biologics and vaccines, how SARS-CoV-2 could be fueling an explosive increase in PFS demand, and how a partnership with a flexible CDMO is the key to success.

60. Scheduling Aseptic Filling For Preclinical And Clinical Batches 9/23/2021

    Flexible production scheduling from a CDMO helps sponsors control costs and timelines even when unexpected development delays occur.