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TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.
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BIO International Convention
Take your business BEYOND expectations at the world's largest biotechnology partnering event! Join over 17,000 biotech and pharma professionals from around the world for four days of BIO One-on-One Partnering, world-class education sessions, and the expansive BIO Exhibition featuring 1,800+ innovative companies.
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SubscribeSubscribers can enjoy each full issue of BioPharm International in print, or via BioPharm apps.
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Industry News
The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.
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The event will be rescheduled for April 20–22, 2021 at the Javits Center in New York City.
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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
AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.
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Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.
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Supplier News
The company has expanded capabilities for aggregate analytics to include dynamic light scattering.
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ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.
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Regulatory News
The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.
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The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.
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FEATURED TOPICS |
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QUALITY SYSTEMS
Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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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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ANALYTICS
Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
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PRODUCT/SERVICES PROFILE
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Catalent Biologics has the capabilities and experience in the development, manufacturing, and analytical services for new biological entities, cell and gene therapies, biosimilars, and antibody-drug conjugates.
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WEBCASTS
Practical Method Development Strategies for the Analysis of Monoclonal Antibodies by Reversed-Phase HPLC
Thursday, May 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Vaccines Illuminated: Biophysical Characterization, PAT, and Quality Control via Light-Scattering Techniques
Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Are You Seeing the Whole Picture? Backgrounded Membrane Imaging (BMI) as a Multi-Use Analytical Tool for Developability Assessment through Late Stage Formulation
Tuesday, May 12, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Accurate Weighing of Reference Standards in a QC Laboratory
Thursday, May 28, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Rescheduled Events
CPhI South East Asia has been rescheduled for July 2020.
PDA’s Annual Meeting has been rescheduled for July 2020.
Bioprocessing Summit Europe has been rescheduled for July 2020.
PDA’s Pharmaceutical Manufacturing Data Science Workshop has been rescheduled for July 2020.
CPhI North America has been rescheduled for September 2020.
CPhI Japan has been rescheduled for September 2020.
Analytica 2020 has been rescheduled for October 2020.
Interpack 2020 has been rescheduled for February 2021.
Interphex 2020 has been rescheduled for April 2021.
more events
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eBook
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The Pharmacopoeia Compliance Series features a description of ways biopharma companies can participate in monograph development, a case study of a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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