BioPharm International-03-01-2016

Experts in the field share some best practices for optimizing process economics in biomanufacturing.

The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.

The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.

Policy makers debate strategies for promoting access to less costly medicines.

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

Thought leaders tackle drug shortages and biomanufacturing challenges.

Data integrity is a widespread, global problem that must be addressed.

The biopharmaceutical outsourcing market starts 2016 with company expansions, acquisitions, and new offerings.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.

Microbial models offer some exciting production alternatives.

Miniature bioreactors add value by reducing validation efforts.

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