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Top Stories
A $1.7-billion acquisition of CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
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The Association of the British Pharmaceutical Industry (ABPI) has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service from potential shortages in a 'no-deal' Brexit scenario.
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INTERPHEX 2019 KEYNOTE SERIES
How is the industry meeting capacity demands for biologic-based drugs? Experts discuss ways to address production-related challenges.
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Industry News
Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.
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The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.
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Biopharma News
Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.
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The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.
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Supplier News
The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.
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A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.
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Regulatory News
The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
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The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.
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OUTSOURCING
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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DRUG DEVELOPMENT
Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.
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QUALITY SYSTEMS
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
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Events
April 2–4, 2019
April 14–17, 2019
April 30–May 2, 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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