Featured Pharma Online Editorial

81. EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

82. ICH Final Q13 Guideline For Continuous Manufacturing: What It Means 12/16/2022

    The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.

83. Cleanroom Gowning Programs Compliant With EU GMP Annex 1 12/15/2022

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

84. Pharma Process Validation: Initial Conclusions Are Often Deceptive 9/26/2022

    As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.

85. A CTO's Journey Into Continuous Biomanufacturing 8/24/2022

    At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.

86. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

87. FDA Publishes Guidance For Biopharma Container And Carton Label Design 6/13/2022

    The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.

88. FDA Releases Pre-Launch Activities Importation Requests (PLAIR) Guidance 5/24/2022

    The FDA has finalized the draft guidance describing the policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for U.S. market launch based on anticipated approval of a pending NDA, ANDA, BLA, or combination product assigned to CDER.

89. Small Molecule Drug Discovery: Can AI Do It All? 4/27/2022

    The hope is that AI can solve the single most challenging problem at the heart of modern drug discovery: the reliable prediction of novel small molecule drugs that potently bind to a disease-causing protein and alter its function. This article discusses the challenges and how we can position ourselves to navigate them.

90. 6 Tips To Ensure Your NDA/BLA Is Ready For FDA Review 2/25/2022

    When preparing a marketing authorization application for an NDA or a BLA, one aspect that is easily overlooked by small start-ups and mature multi-product drug sponsors alike is verification that all commitments made to the FDA have been completed and that evidence of this has been submitted to the agency.