FEATURE ARTICLES
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
- A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
- Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
- Should You Be Using Unique Container Identification?
- Developing & Manufacturing Oligonucleotides: An Overview
- The Influence Of Flows In cGMP Architectural Design
- The ADC Market Is Ripening For Disruption
- Are You Taking The HPCs In Your ADCs Seriously?
PHARMA ONLINE WHITE PAPERS
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Optimizing Aliquoting For Robust Cell And Gene Therapy Processes
Explore the challenges of liquid handling in cell and gene therapy processes as well as innovative solutions to simplify aliquoting in modern bioprocesses.
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Five Essentials For Accurate Oligonucleotide Chemistry3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing From Experienced Industry Leaders8/22/2024
Testing for nitrosamines - potential carcinogens present in food, beverages, cosmetics and pharmaceuticals - is vital in the creation of Active Pharmaceutical Ingredients (APIs) and drug products.
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Revolutionizing Drug Discovery From "Undruggables" To AI6/10/2024
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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Purity Analysis Methods For Synthetic Prime Editing Guide RNAs9/8/2023
Develop a fast, easy workflow for the purity analysis of complex pegRNA molecules along with a robust denaturing technique for pegRNA with high levels of secondary structure.
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Mitigating Nitrosamine Risks In Pharmaceuticals6/25/2024
Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.
PHARMA ONLINE APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
- 09.19.24 -- Meeting Accelerated Timelines Using Solid Form Screening And Rapid Formulation Selection
- 09.19.24 -- FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
- 09.18.24 -- Accelerate Your Drug Development Program
- 09.18.24 -- Disinfecting & Residue Management In Cleanroom Environments
- 09.17.24 -- Advancing Drug Delivery: Safety, Reliability, And Innovation
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
The modern microbiology laboratory is starting to look very different from the laboratory of even 10 years ago. The work will be similar, yet technology will have advanced. Automation, in particular, is taking center stage. Check out the latest e-book from Pharmaceutical Online.
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