05.25.21 Are You Approaching LIMS Validation Correctly?
Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights
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A simple Route 80 traffic stop for tinted windows and tailgating led to the arrests of two men driving with 360 pounds of marijuana from Canada to New York City, prosecutors said at a court hearing on Friday.
Highway police who arrested Shawn Porter and Jeremy Windoloski in Lodi last week allegedly noticed duffle bags packed away in the back of their Chevy Tahoe. Inside the bags were heat-sealed packages of marijuana with an estimated street value of $1.5 million, according to authorities.
Despite facing first-degree drug charges, a Superior Court judge on Friday ordered that Porter, 34, and Windoloski, 23, go free while their cases are pending. The pair had been held in Bergen County Jail since their arrests on April 27.
02.16.21 Do These Recent Warning Letters Signal A Shift In FDA Enforcement?
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Featured Editorial
By Barbara Unger, Unger Consulting Inc.
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.