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Top Stories
More consistent and reliable production processes are critical for advancing innovative treatments.
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Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical.
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Industry News
The National Science Foundation grant will be used to commercialize a synthetic biology platform for cancer drug development.
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Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.
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Biopharma News
The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.
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Supplier News
The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.
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Quartzy, an online laboratory supply management company, will offer lab products from Bioline, Biotium, and MP Biomedicals.
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Regulatory News
The recommended drugs include two orphan medicines and three biosimilars.
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AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
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FEATURE TOPICS |
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ANALYTICS
Process analytical technology tools have enabled manufacturers to monitor and control their production processes.
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bioLIVE
9-11 October 2018, IFEMA, Madrid, Spain
bioLIVE is a new focused event, with an exhibition and a live content stage, that establishes premium class, global leadership in bioprocessing and manufacturing. The event aims to bring the small and large molecule worlds together, creating a unique platform where both industries can learn from each other. Running adjacent to CPhI Worldwide, bioLIVE is a truly global hub for the biopharma community to do business, network, and learn.
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QUALITY SYSTEMS
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
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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.
 www.cbinet.com/cleaning
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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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24th Annual Validation Week
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry.
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Events
August 13–14, 2018
August 15–16, 2018
August 21–23, 2018
more events
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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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