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Top Stories
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
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The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.
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Industry News
The UK BioIndustry Association (BIA) has issued a statement welcoming the publication of the Life Sciences 2030 Skills Strategy, a report setting out how the life sciences sector in the United Kingdom will develop future talent.
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WuXi’s R&D team will be developing and manufacturing 2019-nCoV-neutralizing antibodies at the company's four GMP facilities.
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Supplier News
The new 1800-m2 building houses more than 50 employees and features non-GMP laboratory space and a GMP analytical laboratory.
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The company announced it will be unveiling a new name, Jones Healthcare Group, and a new corporate logo as it celebrates 100 years in the health and wellness markets.
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The Digital Path to Pharma Quality Management
Access an online resource with useful tools and practical information on The Digital Path to Pharma Quality Management. The site provides useful insight on metrics for quality manufacturing, batch record trends, going paperless, and more.
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Bio/Pharma News
Abcam has purchased Applied StemCell’s (ASC’s) gene editing platform and oncology product portfolio, adding comprehensive cell editing capabilities and engine to support expansion of existing “off-the-shelf” cell lines.
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Clinical manufacturing of the therapy will take place at Lonza's Houston, TX, and Netherlands cGMP manufacturing sites.
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Natoli Values Knowledge
By solving real-life issues with the manufacturing of capsules, we’ve gained a wealth of knowledge about the encapsulation industry. We’re dedicated to supporting our encapsulation customers, and that means offering valuable knowledge and insight on firsthand industry issues. And you can learn solutions to common encapsulation challenges through hands-on training! Join us at our Service Center in Cypress, California for a course on encapsulation processes. Seating is limited so
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Regulatory News
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended that Givlaari (givosiran) be granted marketing authorization in the European Union.
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The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Featured Topics |
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REGULATORY
Pressures on FDA will affect industry’s success in bringing new therapies to market.
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MANUFACTURING
Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality
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DEVELOPMENT
Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.
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TAKE THE SURVEY
Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
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Events
February 17–19, 2020
February 23–26, 2020
March 1–5, 2020
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eBOOKS
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In Pharmaceutical Technology's ongoing 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, building a quality culture, and essentials for DOE and QRM.
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