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Top Stories
The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.
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Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.
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Industry News
The European Directorate for the Quality of Medicines & Healthcare highlighted the organization's achievements in 2017, including the first mAb monograph.
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Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
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Biopharma News
The company opened its new global headquarters in Japan.
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Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.
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Supplier News
Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.
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The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics's Zilretta (triamcinolone acetonide extended-release injectable suspension).
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Regulatory News
The European Medicines Agency recommended Novartis' Kymriah (tisagenlecleucel) and Kite's Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment.
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FEATURED TOPICS |
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SUPPLY CHAIN/LOGISTICS
Increased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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QUALITY SYSTEMS
Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems.  www.cbinet.com/dataintegrity
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ANALYTICS
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
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MANUFACTURING
Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.
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Events
August 13–14, 2018
August 15–16, 2018
August 21–23, 2018
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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