BioPharm International
August 01, 2019
Features
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Successful process intensification with inline dilution requires effective monitoring and control.
August 01, 2019
Regulatory Beat
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New tools and policies aim to support more complex manufacturing processes.
August 01, 2019
Features
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Experts explore the role gene-editing techniques can play in regenerative medicine and cell-line development.
August 01, 2019
From the Editor
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Half a century after man first walked on the moon, space-based science is exploring benefits for Planet Earth.
August 01, 2019
Ask the Expert
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Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
August 01, 2019
Features
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Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
August 01, 2019
Features
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Higher cell densities are driving innovations in harvesting, including closed systems for intensified processes.
August 01, 2019
Features
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Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
August 01, 2019
Features
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Despite the growing popularity of single-use technologies in biomanufacturing, there are still instances where stainless steel is the better option.
August 01, 2019
Features
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Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
August 01, 2019
Cover Story
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Now that the first genetically modified cell therapies are being manufactured, the industry must move beyond “whatever works” to meet growing demand.
August 01, 2019
Features
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Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
August 01, 2019
Features
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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.
August 01, 2019
Product Spotlight
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Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.
August 01, 2019
Product Spotlight
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Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work.
August 01, 2019
Issue PDF
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Click the title above to open the BioPharm International August 2019 issue in an interactive PDF format.