Search results for " Europe" in Articles / App Notes
Article
Moving Biosimilars Forward in a Hesitant Market
Still, Gabrielson notes that the US lags roughly 10 years behind Europe in marketing biosimilars, with the first biosimilar, Zarxio (filgrastim-sndz), approved in the US in 2015 (1). “We’re looking at…
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Bracing for a Future Wave of Advanced Therapies
Rich development pipeline
ARM’s industry evaluation shows that, across North America, Europe, and Asia Pacific in 2023, the field of CGTs saw more than 2500 developers throw their hat into the rin…
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Democratizing GMP Manufacturing for the New Therapeutic Pipeline
PharmTech Europe discusses technology that enables the “democratization” of mRNA manufacturing with Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, …
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Report from the 12th Plasma Product Biotechnology Forum
On a related topic, Dominika Misztela, Senior Director for Regulatory Policy Europe at PPTA, discussed advances and ongoing regulatory policy challenges for plasma fractionators. There is a significan…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
It's not only in this country; it's in the Far East and in Europe as well. So, it has evolved slowly, never as fast as I would like these things, but I'm the person who likes playing with the technolo…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
The April announcement focused on the Asia Pacific and Australian regions, but the collaboration’s benefits are already available to users in North America and Europe, says Waters.
Tive offers non…
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Gene Therapies Push Viral Vector Production
Some of the serotypes have been successful preclinical and clinical followed by regulatory approval in both Europe and the United States. “This makes it a popular starting point for gene therapy, alth…
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The Outlook for CMO Outsourcing in 2019
…, the United States, relatively lacking in microbial CMOs and GMP capacity greater than 100–200 L; Europe is the clear leader in microbial CMOs and GMP capacity.
When developer respondents to …
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Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
and European Markets, online database (www.biopharma.com [5]).
8. R.A. Rader, E.S. Langer, Contract Pharma, p 46-49 (May 2018).
9. R. A. Rader, Genetic Engineering & Biotechnology News (GE…
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Understanding Validation and Technical Transfer, Part I
The International Council for Harmonization (ICH), an organization composed of regulatory authorities from the US, Europe, Japan, Canada, Switzerland, Brazil, China, and the Republic of Korea, and rep…