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Top Stories
The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.
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Moving forward with gene therapy development requires a "quantum leap" in manufacturing capabilities.
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Industry News
Improving the manufacturing of gene therapy vectors will be crucial to making advanced treatments accessible to more patients who need them, agreed panelists at the 2018 Galien Forum.
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Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.
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Biopharma News
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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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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Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com
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Supplier News
GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.
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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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IVT's 6th Annual Laboratory Week
IVT's 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Hear from FDA and choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding analytical procedures and methods validation, stability testing and lab data integrity.
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Regulatory News
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
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The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
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SCALE UP
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
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MANUFACTURING
Recent equipment and updated product options offer improvement to a range of biopharmaceutical manufacturing tasks.
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Events
December 3–5, 2018
December 10–12, 2018
January 21–23, 2019
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eBook
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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