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Top Stories
Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
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A solar panel installation at Novo Nordisk's North Carolina facility was initiated in March 2019 as part of the company's commitment to zero environmental impact globally.
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Industry News
The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.
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MilliporeSigma event scheduled to recognize biotech challenges and support development potential.
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Biopharma News
In collaboration with Pall Corportion, biotech company Freeline completed the first full-scale run at its newly commissioned, GMP gene-therapy manufacturing facility in the UK.
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A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.
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Supplier News
Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.
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The Vaccine Development and Bioprocess Cell Culture Technology Day will take place on May 16, 2019 in Baltimore, MD.
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Regulatory News
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
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FEATURED TOPICS |
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SCALE UP
The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.
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OUTSOURCING
Contract manufacturing organizations need to adapt to successfully overcome the specific challenges posed by complex therapies.
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ANALYTICAL METHODS
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the expertise needed for complex therapeutic classes.
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BIO INTERNATIONAL 2019 EXHIBITOR SHOWCASE
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Catalent Biologics provides advanced technologies and tailored solutions for biologic development from DNA to commercial supply.
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From the company that has brought you more than 40 years of pharmaceutical laboratory instrumentation, including the BIOne Single-Use Bioreactor System, Distek is proud to present the BIOne Bioprocess Control Station.
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Eurofins BioPharma Product Testing is the largest network of bio/pharmaceutical GMP product testing laboratories providing comprehensive laboratory services for the world’s largest bio/pharmaceutical companies.
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NEW PRODUCTS AND SERVICES
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Nova Biomedical is a technology company based in Waltham, Massachusetts that provides automated cell culture analyzers for pharmaceutical and biotech markets.
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Events
May 15–16, 2019
June 3–6, 2019
June 18–20, 2019
more events
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eBook
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Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.
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