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Top Stories
The partnership will center on the development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase I clinical development, using its proprietary RNAi platform technology.
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The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.
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Industry News
Published on Oct. 29, 2019, the study focuses on the multidrug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa) and how it can be used to develop new and sustainable antibiotic treatments.
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A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more from leading practitioners in the field of chromatography.
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Biopharma News
The new facility is 15,000 ft2, which includes 8000 ft2 of lab space and 7000 ft2 of office space.
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Breaking with tradition, a compounding facility won for overall operational excellence, while biopharma facilities took home awards in various categories.
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Supplier News
The approval marks the first time a new glass composition has been approved by FDA since the approval of borosilicate glass more than 100 years ago.
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The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.
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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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Regulatory News
Showing gains of 54% compared with 2018, results from a 2019 study showed that nearly three-quarters of pharma barcodes meet Drug Supply Chain Security Act requirements.
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The report focuses on information from stakeholders, published research, and economic analysis of market conditions from an analysis of drug shortage data and development of recommendations by the inter-agency Drug Shortage Task Force led by FDA.
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FEATURED TOPICS |
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REGULATORY
The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.
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QUALITY SYSTEMS
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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November 3-6, 2019
November 5-7, 2019
December 4–5, 2019
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The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.
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