Search results for " Europe" in Articles / App Notes
Article
Climate Change in Outsourcing
On the negative side, governments and private insurers, especially in Europe but increasingly in the United States as well, have forced down the prices they are willing to pay for drugs and are refusi…
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Advancing QbD in the EU
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD) concepts over the past 10 years. In 2003, EMA set up a team to back activities in pro…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Levine sees a similarity between the new FDA guidelines and the current guidelines in Europe. “They follow very closely along the lines of the EU law,” he says. Levine notes however that there are a f…
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Contract Manufacturing Through the Years
The generic API business was still dominated by European companies, and custom manufacturing was a small piece of the business as the global bio/pharma companies had large internal laboratories and ma…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The European Medicines Agency (EMA) approved the first mAb biosimilar developed by Celltrion and Hospira in 2013 (infliximab: Remsima/Inflectra). Development of clear, regulatory approval pathways for…
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Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…
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Trends in Downstream Bioprocessing
• European respondents reported slightly less concerns vs. US respondents concerning chromatography (17.7% for U.S. vs. 14.8% for Europe). In 2009, 33.3% of Western Europeans vs. 14.5% of U.S. respond…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Julie emphasized that 74% of the plasma product related sales comes from Europe and North America but stressed all the unmet needs in the emerging countries. The industry needs to be prepared to also …
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Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Early biotechnology products in the US and Europe were characterized by low titers and low cell densities using various cell hosts (1, 2). Most companies had few recombinant products licensed or in de…