Production Featured Articles
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Imagine The Future: Enhanced Oligonucleotide Synthesis
3/4/2024
Learn about flexible control software that has revolutionized the way method creation, evaluation, and process optimizations for scale-up are completed.
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Early Development Considerations For NCE Success: Quality Systems
3/1/2024
Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.
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Modified Release Formulations: Extending Drug Commercial Lifecycle
3/1/2024
A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.
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Insights Into GMP Manufacturing Of RNA-LNP Drug Products
2/29/2024
Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, facility design, and strategic collaborations.
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Three Tips For Achieving Accelerated Drug Discovery And Development
2/29/2024
Unlocking the potential of AI and ML, digital twins, and other advanced analytics for accelerated drug discovery requires good data on which to build.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
2/27/2024
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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Getting The Most From Your Inline Buffer Formulation System
2/26/2024
An automated, integrated, responsive inline buffer formulation system can help eliminate the need for intermediate storage, reduce facility footprint, and accelerate timelines.
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.
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Constraints And Solutions For Biopharmaceutical Manufacturing
2/6/2024
Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.