Search results for " API synthesis and manufacturing"

Article Advances in Engineering of Protein-Based APIs
Advances in Engineering of Protein-Based APIs New platform technologies, advanced modeling tools, and addressing patient needs are important developments. By Cynthia A. Challener …

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches. By Cynthia A. Challener For a vaccine to be effective, the components of the disease o…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API. By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…

Article Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …

Article Understanding Validation and Technical Transfer, Part 3
Understanding Validation and Technical Transfer, Part 3 Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Part 1 |…

Article Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA. By Siegfried Schmitt Q: We are a contract manufacturing organization (CMO), sp…