Industry Insights

81. The Shift From CSV To CSA 7/9/2024

    Explore current industry challenges, the urgent need to implement Computer System Assurance (CSA), and an approach to aid the pharmaceutical sector in understanding and embracing this essential shift.

82. Identify And Quantify AAV Fill States Using Analytical Centrifugation 4/24/2024

    Purified AAVs are prepared as a variety capsid species. To ensure gene therapy safety and efficacy, it is crucial to characterize and quantify those species.

83. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

84. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

    The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

85. CRISPR Gene Editing, CDMOs, And The Art Of "Just Right" 6/10/2024

    Learn how finding the right combination of capabilities and expertise in a CDMO can set you up for success and keep your innovative project on time and within budget.

86. FDA Remote Inspections Guidance 2/8/2023

    Since the COVID-19 pandemic first hit, remote audits and inspections have been essential. Learn about remote audits and inspections and how audit management software can make the process easier.

87. Can We Eradicate Tech Transfer? 9/23/2020

    While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

88. In Silico Approaches Towards Automated Biomanufacturing 11/6/2023

    As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

89. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

    Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

90. Standardization And Flexibility In Aseptic Filling

    Standardization and flexibility in aseptic filling were thought to be mutually exclusive. But what if there was a standardized system with flexibility built into the aseptic process, so you didn’t have to choose?