Control and analysis of protein aggregation is an increasing challenge to pharmaceutical
research and development. Due to the nature of protein interactions, protein aggregation …

Abstract The US and European Pharmacopeias require subvisible (≥ 10 and≥ 25 µm) and
visible particulate testing of therapeutics to ensure their safety and suitability for clinical use …

Completely revised and updated to reflect the significant advances in pharmaceutical
production and regulatory expectations, this third edition of Validation of Pharmaceutical …

Micro-flow imaging (MFItm) has been shown to be more sensitive than light obscuration (LO)
methods for measuring subvisible proteinaceous particles in protein formulations. Given the …

Providing a well-written and easy-to-read review of the subject, this reference describes the
most recent breakthroughs in the validation and execution of testing schemes for parenteral …

Written by an expert in the industry, this text addresses the specifics of contamination,
including particle origination, characterization, identification, and elimination, with a special …

The reconstitution of freeze-dried products is usually determined by visual inspection with
the naked eye. This can inevitably lead to significant variability in the ability to detect …

This chapter discusses the biophysical methods for size distribution analysis of
biopharmaceutical protein products. Protein aggregates, conformational variants, reversible …

The Parenteral Drug Association published the authoritative summary of best practices in
sterile filtration and validation of sterile filtration in its 1998 TR. Filter validation is an …

The control of extraneous particles and prevention of their gaining access to injectable
products or medical devices is a key issue in pharmaceutical manufacture. Particles …