Guest Columns
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How To Unlock Efficiency In MES Integrations
5/16/2024
This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.
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How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing
5/15/2024
QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.
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Trends To Track: Outbound, Inbound Biopharma Supply Chain Advances
5/10/2024
Here's an overview of advancements in technology and industry built around biopharmaceutical supply chain and logistics, including packaging and temperature controls.
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Gene Therapy: Global Market Trends & Notable Developments
5/8/2024
New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.
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Addressing Challenges In Serialization For Complex Therapeutics
5/7/2024
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
5/6/2024
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
5/3/2024
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview
5/2/2024
This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
5/1/2024
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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Assessing pDNA Purity For Cell & Gene Therapies
5/1/2024
Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.