TOP STORIES
FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.
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An NIH study of a COVID-19 vaccine is enrolling Seattle-based healthy adult volunteers.
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Industry News
USP technical advisors will offer assistance to drug developers to ensure material quality and testing.
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The facility, which handles discovery chemistry services, will accelerate its operations over the next few weeks while taking precautions to guarantee the health and safety of its employees across every site.
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Biopharma News
The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.
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Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.
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Supplier News
The acquisition will expand Dover’s biopharma and hygienic applications capabilities by enhancing its portfolio of flow control technologies with flow rate sensors.
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The program features clickable PDFs and videos that display the best practice applications to clean and disinfect key equipment and surfaces, while allowing for customers to find the suitable cleaning products for their cleanroom operations.
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Regulatory News
The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.
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Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.
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FEATURED TOPICS |
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REGULATORY BEAT
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
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QUALITY SYSTEMS
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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UPSTREAM PROCESSING
The future of raw material sourcing for mAb production may lay in the sustainability of the source and the added benefits of newer technologies.
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PRODUCT/SERVICES PROFILES
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
Rescheduled for July 2020
Interphex 2020 has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
CPhI North America has been rescheduled for September 2020.
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
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eBook
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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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