BioPharm International
October 01, 2018
Guest Editorial
31
10
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
October 01, 2018
Cover Story
31
10
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
October 01, 2018
Peer-Reviewed Research
31
10
This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.
October 01, 2018
Features
31
10
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
October 01, 2018
Features
31
10
Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.
October 01, 2018
Ask the Expert
31
10
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
October 01, 2018
Features
31
10
Applied throughout a product’s lifecycle and across a company’s portfolio, quality risk management and knowledge management will enable more agile manufacturing and better quality standards in the future.
October 01, 2018
Features
31
10
Non-destructive surface area measurement can improve stability testing.
October 01, 2018
Issue PDF
31
10
Click the title above to open the BioPharm International October 2018 issue in an interactive PDF format.
September 12, 2018
Regulatory Beat
31
10
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.