Featured Articles
-
De-Mystifying Regulatory Support During Viral Vector-Based Development
4/15/2025
Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.
-
A Novel Approach To Improving AAV Titers
4/8/2025
As demand for AAV-based therapies rises, optimizing production processes is essential. By utilizing existing technologies, tailored platforms, and optimized formulations, titers and productivity can be enhanced.
-
Implementation Of Multi-Column Chromatography Systems
4/4/2025
Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.
-
Tablet Manufacturing Technologies For Solid Drug Formulation
4/2/2025
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
-
Advantages Of Spray-Dried Mannitol In Roll Compaction
4/2/2025
Pharmaceutical excipients like mannitol enhance formulation stability, flowability, and compressibility, which are crucial for robust tablets. Read how these properties improve patient compliance.
-
Navigating Next-Generation Quality Control Strategies For AAV Testing
3/10/2025
AAV-based gene therapies, while promising, require rigorous quality control through advanced methodologies to ensure safety, efficacy, and regulatory compliance.
-
Improving API Solubility
3/3/2025
Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.
-
Monitoring Microbial Contamination Of Mammalian Cell Cultures
2/21/2025
Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.
-
Key Regulatory Considerations For The Next Wave Of Gene Therapies
2/21/2025
The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.
-
What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product
2/19/2025
Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.