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Top Stories
The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.
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Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.
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Industry News
FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.
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The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.
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Biopharma News
TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.
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The organization will utilize the cancer center's Research for Biologics and Immunotherapy Translation platform for the development of therapeutic monoclonal antibodies against a novel immune checkpoint target.
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Supplier News
Bayer will use ProBioGen's GlymaxX technology to maximize the potency of its antibody drug candidate in development for oncological indications.
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The company's Custom Single Run product line now has available bioreactors with working volumes of up to 6000 L.
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Introducing ABITEC's new line INJECTA™ parenteral grade lipid excipients. Our excipients enable improved solubilization of injectable active pharmaceutical ingredients (APIs). INJECTA lipid excipients undergo secondary sterile filtration and aseptic processing in state-of-the-art facilities to ensure products are of the highest quality. The entire INJECTA product line is tested for pyrogens, microbial contaminants, elemental impurities, and particulate matter by validated testing protocols.
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Regulatory News
FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.
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QUALITY
Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.
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ANALYTICAL METHODS
Oligonucleotides, which are classified as both small molecules and biomolecules, pose unique analytical challenges. High-resolution mass spectrometry is becoming a method of choice for their development.
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OUTSOURCING
CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry's continued growth.
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September 18–19, 2019
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The editors examine the technology, practices, and regulatory approval questions facing
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