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BioPharm International-06-01-2020
BioPharm International
Following Guidelines During a Crisis
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.
Finding New Efficiencies in Clinical Trial Logistics
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.
2019 Investments Centered around Cell and Gene Therapies
June 01, 2020
Operations
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Previous investments set a foundation for later efficiency improvements.
What’s Next in Air Transportation
June 01, 2020
Operations
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The future will bring changes for temperature-controlled container rental companies.
Are We All In This Together?
June 01, 2020
From the Editor
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Achieving herd immunity will require testing, data, a vaccine, and public support.
New Tools Facilitate Automated Process Control
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.
Plasma-Based Antibody Therapies Battle Against COVID-19
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.
The Role of Incubators in Cell and Gene Therapy Development
June 01, 2020
BioBusiness
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Working with incubators can provide cell and gene therapy developers with more opportunities.
Good Manufacturing Practices: Challenges with Compliance
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.
Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics
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.
Challenges, Tools, and Strategies for Data Integrity Protection
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.
The Importance of Partnering for Bioanalytical Studies
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.
Generic Drugs in Spotlight as Pandemic Creates Shortages
June 01, 2020
Regulatory Beat
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FDA and the US Congress support innovation and access to cheaper medicines.
BioPharm International, June 2020 Issue (PDF)
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.