Current Issue

Aug 01, 2018
BioPharm International
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
Aug 01, 2018
BioPharm International
The changing regulatory and manufacturing environment is ushering in a new approach to drug development.
Aug 01, 2018
BioPharm International
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.
Aug 01, 2018
BioPharm International
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Aug 01, 2018
BioPharm International
More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
Aug 01, 2018
BioPharm International
Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.
Aug 01, 2018
BioPharm International
Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
Aug 01, 2018
BioPharm International
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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