TOP STORIES
The agreement centers around the development of new stem-cell derived allogeneic T-cell therapies for the treatment of cancer.
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The amount was the third highest year recorded and investment has increased more than 400% since 2012.
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Industry News
The new course is directed at analyzing the skills gap in the manufacture of cell and gene therapies as they progress toward manufacturing at scale.
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The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.
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Biopharma News
The drug treats adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.
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As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.
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Supplier News
The new company will work to provide the manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies through individual company products and expertise.
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The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.
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Regulatory News
The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
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FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
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MANUFACTURING
Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.
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DOWNSTREAM PROCESSING
Temperature-sensitive biologics are lyophilized to preserve therapeutic viability, but the process presents complexities and challenges that are as yet not fully understood.
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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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