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Top Stories
Moving forward with gene therapy development requires a "quantum leap" in manufacturing capabilities.
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The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
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Industry News
While recognizing the unsung work of scientists in corporate research and development, the Galien Awards remind the industry of its priorities: patients and future patients within the global community.
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Pharmapack Europe expects further increases in innovation across packaging and drug delivery to mirror overall industry trends.
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Supplier News
Under the new long-term agreement, Sartorius Stedim Biotech will continue to offer Lonza media and buffer products under non-exclusive terms.
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In preparation for the upcoming US Drug Supply Chain Security Act deadline, Metrics Contract Services has expanded serialization capabilities at its oral solid-dose commercial manufacturing site in Greenville, NC.
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Bio/Pharma News
AstraZeneca is set to divest US rights to Synagis (palivizumab) to Swedish Orphan Biovitrum (Sobi), a biopharmaceutical company focused on rare diseases, for $1.5 billion.
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The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.
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Regulatory News
The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.
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The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
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QUALITY SYSTEMS
This article will explore the requirements for media and supplements needed to maintain newer cell lines, such as those based on human cells and fungal cells.
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SUPPLY CHAIN
New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
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OUTSOURCING
The growth in adoption of single-use systems for commercial manufacturing will be dramatic in coming years.
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November 28–29, 2018
December 3–5, 2018
December 10–12, 2018
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics. |
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