Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Using Single-Use Technologies in Downstream Processing
The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
Aseptic Processing: Keeping it Safe
Viral Detection Technologies Must Continue to Evolve
Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.
Optimizing the Delivery of Cell-Culture Additives
When using media supplements in biologics, it is important to have a key understanding of both the supplement and the base medium to ensure high titer and stability.
Endotoxin Test Concerns of Biologics: The Role of Endotoxin as a Quality Indicator in Biologic Manufacturing Processes
Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.
Unravelling the Complexity of EU’s ATMP Regulatory Framework
The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.
For Big Ideas, Big Action Is Needed
As biopharma enjoys success, it cannot ignore pressing patient access questions.
CDMOs Cautiously Address Expansion
While all market signs are pointing up, memories of past setbacks may discourage CDMOs from expanding capacity.
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Robust Optimization, Simulation, and Effective Design Space
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
High-Pressure Homogenizer Reduces Maintenance
GEA’s Panther NS3006L high-pressure homogenizer is a standalone unit designed to reduce particle size to nanometer ranges.
Bioreactor Harnesses Single-Use Process
Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.
BioPharm International, July 2015 Issue (PDF)
Click the title above to open the BioPharm International July 2015 issue in an interactive PDF format.
