Gottlieb Tackles Opioids, Drug Costs, and Innovation
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies.
CDMOs: New Administration, New Frontier
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
Just the Biopharma Facts, Please
Amid debate about “fake news,” peer-review papers offer vital, objective insight.
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
Optimizing Cell-Culture Media
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
Keeping it Clean: Biopharmaceutical Cleaning Validation
Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.
The Role of Quality Standards for Biomanufacturing Raw Materials
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Avoiding Investigational Failures and Discrepancies
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Analytical Strategy in the Development of Biosimilars
The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.
BioPharm International, August 2017 Issue (PDF)
Click the title above to open the BioPharm International August 2017 issue in an interactive PDF format.
