FEATURE ARTICLES
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
- Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?
- The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
- Computer Systems Validation Pitfalls, Part 1: Methodology Violations
- Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients
- Sterility Assurance: The Fundamentals
- Expert Voices: Why Aren't QC Labs Fully Automated Yet?
- What To Do When Your Regulatory Findings Need Quality Risk Management Action
PHARMA ONLINE WHITE PAPERS
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Optimizing End-To-End Contract Analytical Support For Cell And Gene Therapies
The development and production of CGTs presents unparalleled complexities. Learn how a partner with robust end-to-end services can help you overcome challenges at every step of the drug lifecycle.
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Creating Sustainable Data In The Laboratory4/24/2024
In a laboratory setting, data is everywhere. Learn in-depth about data challenges, the importance of data lifecycle management in laboratories, and the need for data sustainability.
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Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying3/10/2023
A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
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Using FT-IR To Identify Unknown Contaminants3/7/2024
Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.
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Epigenetics Application Guide: RNA Modifications9/26/2024
Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Optimizing And Intensifying ADC Aggregate Removal With A DoE Approach
- How To Ensure Correct Component Selection When Outsourcing To A CMO
- Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage
- Mobile USP 797 and 800 Sterile Compounding Pharmacy Cleanroom Trailer
- AAV Empty/Full Ratio Assessment Using The Octet® AAVX Biosensors
NEWSLETTER ARCHIVE
- 10.21.24 -- Are You Ready To Make The Pharma Digital Shift?
- 10.18.24 -- Discover Secondary Packaging Service Providers & Suppliers
- 10.18.24 -- 9 Key Contributing Factors For Maintaining Sterility Assurance
- 10.17.24 -- The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
- 10.17.24 -- Driving Pharma Excellence: Innovations In Sterility, Filtration, And Cleanrooms
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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