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Featured in the Current Issue
Real-time monitoring of product- and process-related impurities remains a challenge.
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The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.
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Cultural and language discrepancies during an audit can be resolved using what many call a "playbook," says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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Industry News
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
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The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards
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Biopharma News
Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.
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Gilead Sciences gains rights to clinical and preclinical programs in Galapagos' portfolio through a 10-year global research and development collaboration.
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Supplier News
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
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Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
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Regulatory News
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company's Norwalk facility.
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The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
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FEATURED TOPICS |
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MANUFACTURING
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
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REGULATORY
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
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UPCOMING WEBCASTS
From Small-Scale Stem Cell Production to Large-Scale hiPSC-Based Drug Development: The Flexibility of Stirred-Tank Bioreactors
Monday, September 16, 2019 at 9am EDT | 2pm BST | 3pm CEST
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Developing a Robust CQA Monitoring Method via Multi-Attribute Monitoring Principles for Therapeutic Monoclonal Antibody Development, Manufacturing, and Lifecycle Management
Tuesday, September 10, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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The Versatility of High Throughput Dynamic Light Scattering in Protein Characterization and Formulation Development
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Native MS for Aggregate and Charge Variant Analysis of Biotherapeutics
Tuesday, August 20, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Events
September 3–4, 2019
September 16–18, 2019
September 18–19, 2019
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eBook
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The editors examine the technology, practices, and regulatory approval questions facing
companies employing single-use technologies for commercial manufacturing.
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