Featured Pharma Online Editorial

91. 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.

92. Considerations For Sterility Test Methods When Working With CDMOs 1/13/2023

    Confirmation of microbial quality of drug products manufactured by CDMOs is a key component of product release. It is important to ensure that laboratory-specific method suitability testing is performed to ensure appropriate recovery of the presence of potential contaminants.

93. 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.

94. 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.

95. 4 Key Takeaways For Combination Products As We Move Into 2023 12/13/2022

    The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.

96. 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.

97. 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.

98. The Environmental Impact Of Biopharma Continuous Manufacturing: Part II 8/22/2022

    Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.

99. 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.

100. The Environmental Impact Of Biopharma Continuous Manufacturing 8/8/2022

     One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.