Guest Columns
-
How To Speed Up Time To Market With CMC Knowledge Management
1/24/2024
Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.
-
Developing A Viral Gene Therapy Manufacturing Process
1/23/2024
There is a growing popularity of adeno-associated virus (AAV) for delivering in-vivo gene therapies, a growing preference of transient transfection systems by biologics companies, and an increasing number of CDMOs offering this system as a platform process. This article describes a transient transfection AAV manufacturing process that uses a triple plasmid transfection strategy into HEK293T cells.
-
Tracking 4 Payload Trends In Drug Delivery Development
1/22/2024
Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.
-
A New Year’s Resolution Suggestion For The FDA
1/22/2024
Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.
-
Need To Improve Your Change Management? Regulators Can Help With That
1/12/2024
The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.
-
Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic?
1/9/2024
The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.
-
Are Single-Use Technologies Always The Answer?
1/9/2024
It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.
-
Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024?
1/8/2024
2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.
-
How To Use Precipitation, Not Protein A Chromatography, For mAb Capture
1/4/2024
Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.
-
Cryo-Shippers: Challenges, Controls, And Logistics
1/3/2024
Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.