- LGM Pharma enhances Analytical Testing Services (ATS) with endotoxin and rapid sterility testing at its Irvine, CA facility.
- New capabilities reduce sterility testing times from 14 to 5 days, offering faster product release for drug developers.
LGM Pharma has announced the expansion of its Analytical Testing Services with the introduction of endotoxin and rapid sterility testing at its Irvine, California facility. This move responds to growing demand for reliable and fast testing for sterile compounds, offering significant benefits for pharmaceutical companies.
The new testing capabilities, including cutting-edge equipment, reduce sterility testing times from 14 days to just five, accelerating the release of sterile products, particularly injectables. This enhanced speed and data accuracy help drug developers, especially smaller pharmaceutical companies and compounding pharmacies, to streamline their processes. The testing also supports compliance with the 503(a), 503(b), and 505(b)2 regulatory pathways.
“LGM Pharma is committed to providing comprehensive services to our clients,” said Shailesh Vengurlekar, Senior Vice President of Quality and Regulatory Affairs. “Our investment in new testing capabilities reflects our commitment to offering fast, accurate, and affordable testing for sterile products.”
The company’s new PCR-based sterility detection system improves throughput and sensitivity, further ensuring compliance with FDA and global regulatory standards. LGM Pharma aims to help clients reduce costs and avoid supply chain complexities, offering a fully integrated solution for drug development and manufacturing.
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