TOP STORIES
Through the agreement, Eli will expand its immunology pipeline with lebrikizumab, Dermira’s novel, investigational, monoclonal antibody designed to bind interleukin-13 with high affinity.
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Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
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Industry News
The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.
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ProBioGen and Lava Therapeutics have closed the cell line development and manufacturing agreement for Lava’s novel bispecific antibody lead candidate.
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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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Biopharma News
The Cell and Gene Therapy Catapult (CGT Catapult) has revealed that the United Kingdom is a favorable environment for cell and gene therapy clinical trials.
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Horizon Discovery Group and Mammoth Biosciences have signed a collaboration and license agreement aimed at the development of the next generation of engineered Chinese hamster ovary (CHO) cell lines to improve biotherapeutics production.
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Supplier News
The renaming comes after the sale of Bosch Packaging Technology to CVC Capital Partners was completed on Jan. 2, 2020.
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The next-generation gene editing system can be applied to the development of novel cell and gene therapies.
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Regulatory News
The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
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FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
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FEATURED TOPICS |
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QUALITY
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
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MANUFACTURING
While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.
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PEER-REVIEWED RESEARCH
This study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.
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February 18–20, 2020
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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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