In nearly all regions and industries, markets for products reflect the impact of globalization. The tactic of competing on price is increasingly giving way to a wider range of factors—including ...

The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls. Although no new statistics or sampling plans are explicitly required by Q10, it goes without saying ...

Since the first marketing approvals of recombinant biopharmaceuticals, the question of which changes in quality attributes, which comprise identity, strength and purity, are acceptable in the life ...