BIO From The Editor and Guest Columns
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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How Eli Lilly's Making Peptides Faster And More Reliably
7/17/2024
Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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More Case Studies: Managing Change In Vaccine Production
7/15/2024
Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.
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Correct But Misleading: AI Hallucinations In Complex Decision-Making
7/11/2024
Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.
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End-To-End mRNA DS And DP Manufacturing Processes
7/10/2024
This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.
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Why Knowledge Workers Must Embrace Standard Work
7/10/2024
Highly educated scientists often resist the notion of standard work because it seems stifling. On the contrary, standard work can increase productivity and creativity.
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Does Single-use Seem Daunting? Try Starting With Standard Assemblies
7/8/2024
You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.
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Using The ADKAR Model In Biopharma Change Management
7/8/2024
Biopharma companies dedicated to continuous improvement are the ones that dominate their market sector. Using the ADKAR model of change management can help.
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Making Cancer Vaccines Is Complex; New Platform Guidance Could Help
7/3/2024
FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.