Search results for " pharmaceutical" in Articles / App Notes
Article
Perfusion in the 21st Century
Konstantinov and CL Cooney, White Paper on Continuous Biopprocessing, Continuous Manufacturing Symposium, Journal of Pharmaceutical Sciences 104:813-820, May 20-21, 2014.
5. C. Challener, “Focus o…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Cheng (currently at Actinium Pharmaceuticals, Inc.) and Dr. Xiao-Ping Dai (currently at Celgene Corporation) for providing valuable input.
References
1. CFR Title 21, Part 211.84: Food and Dru…
Article
Antibody Production in Microbial Hosts
Glycoengineering platforms, display technologies and library creation, and robust manufacturing process development support the use of microbial cells as suitable candidates for pharmaceutical develop…
Article
Aseptic Processing: Keeping it Safe
Jimenez, American Pharmaceutical Review 15 (1), pp. 42–57 (2012).
2. The United States Department of Justice, “14 Indicted in Connection with New England Compounding Center and Nationwide Fungal M…
Article
Breakthrough Drugs Raise Development and Production Challenges
…plained Dorota Matecka, acting branch chief in the Office of New Drug Products in CDER’s Office of Pharmaceutical Quality (OPQ), at the DIA workshop and again at the ISPE/FDA/PQRI Quality Manufacturi…
Article
Robust Optimization, Simulation, and Effective Design Space
ICH Q8, Pharmaceutical Development (1) defines a design space as: “The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
In 2013, according to the Pharmaceutical Research and Manufacturers Association, 69 cell therapies, six of them autologous, or patient-specific treatments, were in clinical trials or being reviewed in…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
While the biopharmaceutical industry is young compared to the small-molecule pharmaceutical sector, it has been of significance for several decades. Some of the processes that are running today utiliz…
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
Securing the Single-Use Supply Chain
Challener, PhD, is a contributing editor to Pharmaceutical Technology.