Search results for "supplements" in Articles / App Notes
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
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
Quality by design for biotechnology products—part 1
…censure, thus requiring continuous updating of the application through burdensome global regulatory supplements, variations, or amendments.
This paper focuses on the factors to consider when appl…
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
…ew of the steady stream of new drug applications (NDAs), biologics license applications (BLAs), and supplements to treat multiple conditions.
One result is that drug approval processes for …
Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Click here to view more Industry Leader Q&As >>
Gunnar Malmquist, Senior Principal Scie…
Article
Cell Culture Media Selection Guide for Your Lab Wall!
Yes, send me a poster >>
Doing cell culture and upstream process development on antibodies, vaccines, or viruses? Then you’ll want this poster. It will help you select the right cell culture medi…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
Cynthia A. Challener
Upstream viral-vector processes can have sig…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…