Validation, Commissioning & Design Featured Articles
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FDA Introduces Quality Management Maturity Program
9/26/2023
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Demystifying Custom Media Development
9/13/2023
Explore four of the most common concerns surrounding custom media development, and how you can avoid potential challenges and get the most from custom formulations.
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Overcome Common Media Scalability Challenges
9/13/2023
Streamline the transition to commercial manufacturing through four key development considerations; format conversion, manufacturability, supply insurance, and batch-to-batch consistency.
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Bioproduction Analytics To Support Optimized Media Development
9/12/2023
Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.
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Enabling Digital Innovation To Transform Cell Line Development
9/6/2023
Establishing an integrated, tailored data management strategy is core to getting the cell line development journey right.
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Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier
8/21/2023
Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.
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Implementation Of MES For Biopharmaceutical Quality
8/16/2023
More life sciences companies are implementing manufacturing execution systems (MES) to improve quality at every step – and get products to patients faster.
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Make Better, Faster Decisions With A Manufacturing Control Tower
8/6/2023
Assess the state of your data and start using manufacturing control towers (MCTs) to achieve heightened efficiency and make decisions with virtual dashboards these towers provide.
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Four Questions To Ask Before Implementing Data Quality Software
8/6/2023
Ensuring high data quality by using data quality software to implement and enforce data quality rules.