BioPharm International-08-01-2018

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

Click the title above to open the BioPharm International August 2018 issue in an interactive PDF format.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.