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Top Stories
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
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FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
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Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
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VIDEO
Plant Models in Biopharmaceutical Manufacturing Barry Holtz, president, iBio CMO sat down with BioPharm International to discuss plant models in biopharmaceutical manufacturing.
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Industry News
AAPS elections for Executive Council will be held in June/July 2017; results announced in August.
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The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.
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Biopharma News
The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.
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The company released an interim analysis from its JULIET study with CTL019.
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Supplier News
The new UPS facility in Colombia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.
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The company will be acquired for $21.75 per share in cash.
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FEATURED TOPICS |
MANUFACTURING
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
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UPSTREAM PROCESSING
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
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ANALYTICS
How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.
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Events
June 19–22, 2017
June 27–28, 2017
September 27–28, 2017
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Reference Books
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Quality by Design (QbD) compiles the best content from BioPharm International and Pharmaceutical Technology to provide valuable insight into the topic and assist in making the business case for QbD, based on the criteria decision makers need to evaluate new initiatives and related technology.
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eBook
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Nearly 60% of the bio/pharma companies responding to a recent BioPharm International survey outsource at least half of their crucial development and manufacturing tasks. In this ebook, the editors report on the biopharma–contract services relationship.
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