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TOP STORIES
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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Tina Morris will be taking on the role of executive director for AAPS.
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BIO International Convention
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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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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
Clinical manufacturing of the therapy will take place at Lonza's Houston, TX, and Netherlands cGMP manufacturing sites.
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J&J’s Janssen Pharmaceutical Companies seeks to develop a vaccine candidate against the novel coronavirus.
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Sartorius Smart Consumables
Cell expansion of the future: MYCAP® CCX combines integral tubing and a specially-designed gas exchange cartridge in the same cap closure. Grow cells in the incubator and passage between flasks without ever opening a flask or going into a biosafety cabinet.
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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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Regulatory News
The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
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The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
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FEATURED TOPICS |
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MANUFACTURING
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
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OUTSOURCING
Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
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QUALITY SYSTEMS
A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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February 18–20, 2020
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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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