Search results for " biotechnology"
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
International companies tend to form partnerships with local pharmaceutical or biotechnology firms to more easily access emerging markets. One such example is the Product Development Partnerships in B…
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Manufacturers Struggle with Breakthrough Drug Development
Emanuela Lacana of CDER’s Office of Biotechnology Products explained further at CASSS’ CMC Strategy Forum (Jan. 27, 2014) that breakthrough drug development requires information on critical quality at…
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EMA Collaborates with HTA Assessment Networks
“SMEs are generally interested in receiving joint EMA/HTA advice, in particular when it comes to advanced therapies,” says Paolo Morgese, chairman of the HTA Topic Group of EuropaBio, a biotechnology …
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Brazil Emerges as Global Biopharm Collaborator
According to Abifina, Brazil’s Fine Chemicals, Biotechnology, and Specialty Industries Association, Latin American countries are still planting seeds to develop and compete in the global biopharmaceut…
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Comparing Protein A Resins for Monoclonal Antibody Purification
In 2007, mAbs accounted for almost half of the top-20 best-selling biotechnology drugs in the US alone, establishing them as an important group of molecules (3). Today, mAbs constitute the single larg…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical and biotechnology companies making products for human use have an obligation to ensure that their products are safe, effective, meet established regulatory expectations and licenses, an…
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Advancing QbD in the EU
EuropaBio, which represents both biotechnology companies and national associations in Europe, said in its comments, published in July 2012 on a proposed revised guideline on variations, that greater r…
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The Future of Biopharma
TREND ANALYTICS
To gain perspectives on these and other trends, BioPlan Associates asked the 425 global subject matter experts and senior participants on its Biotechnology Industry Council to eval…
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The Pharmaceutical Manufacturers Association
Headquartered in Washington, DC, PhRMA represents the country’s leading pharmaceutical research and biotechnology companies.