FEATURED ARTICLES
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An Introduction To Biopharma Facility Design & Layout
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
WHITE PAPERS & CASE STUDIES
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Characterization Of Protective Face Masks
Face masks, such as surgical masks, are intended to prevent large particles from being expelled by the wearer into the environment. This report focuses on the physical characterization of a three-layer pleated mask and a molded cup mask.
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100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine
A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.
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Manufacturing Process Scale-Up For Phase III
Explore factors that pharmaceutical companies of all sizes and experience levels must consider to ensure their formulations are successful during larger-scale manufacturing.
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A Case Study In Real-Time Release Testing
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.
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Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
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Accelerating Generic Approvals: 5 Keys To Being First To Market
Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.