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TOP STORIES
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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The company announced that it has been issued a task order under a present contract with BARDA to use its contract development and manufacturing capabilities and knowledge to assist in the US government’s efforts to deliver COVID-19 vaccines.
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Bioprocess development forum
View our bioprocess development forum, sponsored by Cytiva, to explore insights and solutions to accelerate process development and intensify your process.
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Industry News
Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.
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The UK BioIndustry Association has stated its support of a government led funding initiative, Future Fund, which will support innovative companies in the United Kingdom that will help to ensure the country’s leading position in science, innovation, and technology.
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Challenges in Bulk Drug Substance Management
Final liquid drug substance production and fill–finish activities rarely occur at the same site. Nearly all pharmaceutical and biotechnology companies outsource a portion of their fill–finish needs to CMOs to help them address unexpected demand, satisfy second source policies, or better match scale with need.
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Biopharma News
Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.
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Merck will use Themis’s vector platform to develop a vaccine to prevent COVID-19.
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Supplier News
CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.
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The company has received a $288,000 grant from the COVID-19 Therapeutics Accelerator, part of the Bill & Melinda Gates Foundation, to support a clinical study in Sub-Saharan Africa to find a treatment for COVID-19.
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Regulatory News
The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.
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The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.
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FEATURED TOPICS |
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OUTSOURCING
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
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QUALITY/REGULATIONS
Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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QUALITY SYSTEMS
A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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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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