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Trends and issues in biopharmaceutical development

High Labor Costs May Drive Biologics Manufacturing Offshore

Most consumer goods are manufactured in developing countries where labor rates are relatively low. These lower labor rates provide a cost of goods advantage even though labor represents ~5% for a smart phone and ~10-15% for an automobile. What is the implication for global biopharmaceutical manufacturing where labor contributes ~20-50%...

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Emerging Therapies: CMO’s Tackle Biomanufacturing Challenges

Innovative cell and gene therapies and the resurgent interest in ADC’s (antibody drug conjugates) are emerging therapies that are creating these challenges. The roundtable discussion entitled; Outsourcing and Biomanufacturing Challenges for Emerging Therapies, at BIO 2016 focused on demands for CMO services associated with these therapies. Patti Seymour, Senior Consultant...

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Quality by Design (QbD): Seeing the Glass as Half Full

As the biopharmaceutical manufacturing industry grows and becomes global, companies face demands to improve quality, while reducing costs and increasing output. The road to achieving these goals is through the adoption of QbD. A paradigm shift, when adopted by the FDA in 2004, QbD is modernizing the approach to pharmaceutical development...

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