TOP STORIES
The new business unit, as well as a new leadership team formed by AbbVie, will be effective upon closing of the acquisition in the first quarter of 2020.
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The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.
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Industry News
The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.
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Tim Howard will assume the role of acting ISPE CEO and president after John Bournas steps down from the positions.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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Biopharma News
The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.
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Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.
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Supplier News
Catalent completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy.
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The Ireland-based company can now offer complete elemental impurities testing services.
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Regulatory News
The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.
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FDA continued to demonstrate its flexibility and support for biomedical innovation by approving a number of important new therapies.
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FEATURED TOPICS |
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QUALITY
Investigating deviations or failures of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished
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ANALYTICS
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
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UPSTREAM PROCESSING
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting materials, and they must ensure a steady supply.
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In BioPharm International’s Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, FDA Form 483s, and essentials for quality risk management.
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