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TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The companies are expanding their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases.
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Industry News
Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
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The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.
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Biopharma News
The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.
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The test results could potentially be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use.
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Supplier News
The updated facility is 60,000 square feet and is equipped with bioprocessing capabilities ranging from 10L to 2000L.
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The partnership combines Malvern’s physicochemical characterization expertise and Concept Life Sciences’ chemistry and analytical services to provide services that focus on analytics, know-how, instrumentation, and expert support to customers.
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Regulatory News
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
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FDA has revoked its Emergency Use Authorization hydroxychloroquine and chloroquine, citing new evidence and reanalysis of earlier data confirming that the drugs show no evidence of effectiveness against the coronavirus and raise continued concerns about cardiovascular safety risks.
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FEATURED TOPICS |
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ANALYTICS
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
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QUALITY SYSTEMS
Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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WEBCASTS
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Validation of an LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization
Tuesday, June 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST
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Genotoxic Impurities and Drug Quality:
Lessons from the Nitrosamine Contamination Crisis
Tuesday, July 14, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Adaption of Analytical Tools for PAT Implementation for the characterization of Biosimilars
Europe Broadcast: Thursday, July 30, 2020 at 9am EDT| 2pm BST| 3pm CEST
US Broadcast: Thursday, July 30, 2020 at 2pm EDT| 1pm CDT| 11am PDT
Moderator: Laura Bush, Editorial Director, LCGC
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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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