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Top Stories
The decision was made after it was determined that many of the event’s largest stakeholders would be unable to travel to the conference due to the novel coronavirus outbreak.
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WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.
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Industry News
The “I am RARE, hear me ROAR” event will feature patient artists hoping to raise awareness about their rare diseases.
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The events will feature activities and discussion panels for patients, patient advocates, health care providers, researchers, industry representatives, and government employees.
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Supplier News
Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.
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The Office for Life Sciences of the government of the United Kingdom has designated six new locations in the country as ‘Life Sciences Opportunity Zones’, of which the Harwell Science and Innovation Campus is one.
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Bio/Pharma News
The partnership will begin in the second half of 2020.
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The companies aim to develop novel cell therapies for treating multiple cancers.
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Regulatory News
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
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US and European regulatory officials continue to anticipate supply shortages in multiple areas.
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Featured Topics |
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FORMULATION
Lipid-based solutions offer a natural approach to improving the solubility of cannabinoid-derived products.
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MANUFACTURING
Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.
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QUALITY SYSTEMS
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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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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