Search results for " drug development" in Articles / App Notes

Article Science Focus Fuels Successful Process Development for Startups
The process of drug development is a long one due to tight regulations by the regulatory bodies in the United States and Europe, and hence, biotechnology is not a suitable investment for an investor w…

Article Tackling Analytical Method Development for ADCs
Feb 01, 2015 By Cynthia Challener, PhD BioPharm International Volume 28, Issue 2 The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …

Article ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects. By Feliza…

Article Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…

Article Key Considerations in Biosimilars Development
by:  Raymond Donninger, Joe Bower, Raymond Kaiser, Sian Estdale, John Carlsen Understanding opportunities and challenges across all major phases of development. Biosimilars…

Article Drug Discovery and Development in India
“There is a need for speeding the regulatory processes at all stages of drug development starting from seeking licenses for initiating drug discovery, conducting clinical trials in India to obtaining …

Article Current and Future Trends in Biosimilar Development: A Conversation with GE's Gunter Jagschies
Process Development Forum spoke with Gunter Jagschies, Strategic Customer Relations Lead at GE Healthcare, about current and future trends in biosimilar development. The interview was conducted by D…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article Using Quality by Design to Develop Robust Chromatographic Methods
The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved. The concept of quality by des…

Article Manufacturers Struggle with Breakthrough Drug Development
27, 2014) that breakthrough drug development requires information on critical quality attributes, potential scale-up strategies, comparability exercises, and validation plans. FDA will want to know ho…

Show All Results

Next Page