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Top Stories
A ruling in Oklahoma that Johnson & Johnson's marketing efforts created a public nuisance may establish a precedent of other jurisdictions.
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The transaction is part of Bristol-Myers Squibb's proposed acquisition of Celgene.
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Industry News
The new vaccine will offer protection against the Nipah virus after a single dose.
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ABPI has issued a statement of support in response to the United Kingdom's Prime Minister's recent order of urgent action to boost the numbers of children receiving vaccinations.
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Biopharma News
iBio granted a license to CC-Pharming for the commercialization of its iBio Rituximab drug for treatment of B cell non-Hodgkin lymphomas, chronic lymphocytic leukemia, and autoimmune diseases.
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Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.
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Supplier News
The transaction will reach completion during the fourth quarter of 2019.
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LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.
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Regulatory News
A biosimilar to Eli Lilly's Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.
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While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
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FEATURED TOPICS |
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MANUFACTURING
Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
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ANALYTICAL LAB OPERATIONS
Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
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REGULATORY
Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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QUALITY
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
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UPCOMING WEBCASTS
Expanded Capabilities for Bioanalysis Leveraging a Chromatography Data System
Thursday, Sept. 26, 2019, at 9am EDT | 2pm BST | 3pm CEST
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Understanding Biotherapeutic Product Quality Attributes through a Multi-Attribute Method (MAM)
Lab-of-the-Future
Tuesday, September 17, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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September 3–4, 2019
September 16–18, 2019
September 18–19, 2019
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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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