Industry Insights
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Powder Characterization For Modern Manufacturing
1/11/2012
In this series, I’ve been looking at traditional powder testing techniques, such as tapped density methods and shear analysis, to see how they fit with today’s powder processing needs. Greater efficiency is the goal now dominating pretty much every area of production, so I really do feel it’s appropriate to question whether we have the right powder characterization tools for modern applications. By Tim Freeman, Freeman Technology
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How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned
3/14/2018
When Trevena, Inc. needed to establish a supply chain for its lead compound, oliceridine fumarate — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework.
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Trade Show Employment Bureaus -- Are They Worth The Trouble? Part I
4/6/2000
Recently, I spent a week at Pittcon. If you have not been to this show, you really need to twist an arm or two to go at least once...
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Key Considerations When Evaluating Bioprocess Bag Chambers
8/2/2023
Explore considerations in the selection process of choosing a bag chamber according to E3051 that ensures optimal performance for application and user requirements.
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Solid Tumors: The Next Frontier Of Cancer Immunotherapy
2/14/2024
With the use of advanced in vitro models like Organ-Chips, researchers are gaining a better understanding of CAR T-cell therapy in the context of solid tumors.
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Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
3/8/2021
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.
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Is Your QMS 21 CFR Part 11 Compliant?
12/5/2022
With many options for digital transformation in the quality software sector, there’s never been more opportunity to digitize your QMS. Explore the benefits of a digital QMS and more.
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Is GMP Quality System Auditing Fundamentally Flawed? A Data Integrity Alternative
2/27/2017
Pharmaceutical inspection approaches rely on the evaluation of several or all components of the quality system: quality, production, laboratory, materials, facilities and equipment, and packaging and labeling. One area where it has serious limitations, however, is in the assessment of data management and data integrity.
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Guest Column: Overcoming Powder Testing Limitations
5/11/2011
Flowability — the ease with which a powder flows — is arguably the most important characteristic of powder behavior. Today, the increasing emphasis on more efficient manufacture and continuous processing intensifies the need for reliable, relevant, and precise flowability measurement. By Tim Freeman, Freeman Technology
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Using Lean Strategy To Improve Efficiency In Pharmaceutical QC Labs
3/9/2018
The “lean” principle, originally designed to improve and streamline manufacturing operations, can also be used to transform a QC lab and significantly improve laboratory throughput time, improve productivity, and create a “right first time” (RFT) environment with more predictable performance.