Search results for "manufacturing" in Articles / App Notes
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The purpose of these guidance documents is to promote enhanced understanding of products and processes, to build quality into manufacturing, and to provide the basis for continuous improvement of prod…
Article
Best Practices for Data Integrity
By Jennifer Markarian
Maintaining data integrity is essential for all biopharmaceutical manufacturing operations. BioPharm International interviewed Dan Nelson, Customer Expe…
Article
Innovation vs. Capacity: How CMOs Compete
The contract and manufacturing organization (CMO) industry can be segmented along obvious lines such as API versus drug product manufacturers, biologics versus small molecule, dose form(s) manufacture…
Article
Lessons Learned Accelerate Vaccine Development
“The lack of true platforms, with a few exceptions, means that there is a lack of standard cell lines with associated process and analytical frameworks for the manufacturing and release of products,” …
Article
Aseptic Processing: Keeping it Safe
Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such …
Article
Breakthrough Drugs Raise Development and Production Challenges
New drug applications (NDAs) for breakthrough therapies often contain less manufacturing information than usual, requiring innovative risk-mitigation strategies to ensure product safety. Agency review…
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
Article
Updating Viral Clearance for New Biologic Modalities
Many of these new and evolving biotherapeutics use viruses or virus-related approaches in their manufacturing processes.
Clearance challenges
The challenge of demonstrating viral clearance in …
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Continuous Processing for the Production of Biopharmaceuticals
By Anurag Rathore, Nikhil Kateja, Harshit Agarwal, Abhishek Kumar Sharma
Benefits of continuous processing have been widely demonstrated by a variety of manufacturing industries. With the growing …