Guest Columns
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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.
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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.
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Liposome Drug Delivery: Global Trends & Market Forecast
1/19/2024
Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.
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Understanding Undruggable Targets: Challenges And Progress
1/18/2024
As we continue to discover new treatment approaches, we need to go beyond targeting proteins with well-defined pockets and find other ways to target the undruggable. Two approaches that show promise are PROTACs and molecular glues.
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The Benefits Of Using GenAI In Drug Discovery And Preclinical Development
1/17/2024
The emergence of generative artificial intelligence (GenAI) has the potential to reform early-stage drug discovery and development. Large language models are being harnessed to create novel molecules tailored for specific properties, positioning them as potential drug candidates. It could also unveil previously overlooked therapeutic possibilities. Pharma leaders must ensure they have a sound strategy for this.
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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.
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WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste
1/11/2024
While most nations have regulations and emission standards regarding industrial waste containing antimicrobials, there is no globally accepted framework. This new WHO guidance seeks to establish an independent, scientifically derived framework for applying targets to manage discharges from antibiotic manufacturing facilities. The public comment period ends Jan. 26, 2024.
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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.
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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.
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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.