BioPharm International
June 02, 2020
Ask the Expert
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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.
June 01, 2020
Operations
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The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
June 01, 2020
Operations
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Previous investments set a foundation for later efficiency improvements.
June 01, 2020
Operations
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The future will bring changes for temperature-controlled container rental companies.
June 01, 2020
From the Editor
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Achieving herd immunity will require testing, data, a vaccine, and public support.
June 01, 2020
Cover Story: Process Control
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Automated sampling systems and integration of PAT are overcoming some of the roadblocks to increased automation of biopharmaceutical manufacturing processes.
June 01, 2020
Upstream Processing
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Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.
June 01, 2020
BioBusiness
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Working with incubators can provide cell and gene therapy developers with more opportunities.
June 01, 2020
Quality/Regulations
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
June 01, 2020
Peer-Review Research
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Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
June 01, 2020
Downstream Processing
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Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.
June 01, 2020
Analytics
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Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
June 01, 2020
Regulatory Beat
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FDA and the US Congress support innovation and access to cheaper medicines.
June 01, 2020
Issue PDF
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Click the title above to open the BioPharm International June 2020 issue in an interactive PDF format.