Validation, Commissioning & Design Featured Articles
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State Of Validation
12/20/2023
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey. Find out what the results of this year’s survey concluded.
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Getting CMC Right For Emerging Technologies
12/20/2023
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Early Development Considerations For Late-Stage NCE Success – Part One
12/8/2023
Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.
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ICH Quality Risk Management Guidelines For Biopharma Manufacturing
11/27/2023
Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.
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Your 6 Priority Areas For A Successful 2024
11/27/2023
As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.
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Is It Time To Move On From Your MES Vendor?
11/22/2023
Are you ready to improve your cloud-based solutions? Here are 6 indicators that you are ready to move your manufacturing processes forward with Modern MES.
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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The Power And Potential Of RBM In Clinical Trials
11/8/2023
Risk-based monitoring increases overall trial oversight by balancing “must-do” data collection and “nice-to-have” data against site and patient burden — and, more importantly, patient safety.
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The Problems With Construction Quality In Life Sciences
11/7/2023
In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.
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In Silico Approaches Towards Automated Biomanufacturing
11/6/2023
As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.