BioPharm International-10-01-2018

Guest Editorial

October 01, 2018

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

This article explores the use of single-use mixing technology in a detergent-based virus inactivation step during a monoclonal antibody production process.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

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.

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.

Non-destructive surface area measurement can improve stability testing.

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Regulatory Beat

September 12, 2018

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.