LGM Pharma has expanded its Analytical Testing Services (ATS) with the addition of endotoxin and rapid sterility testing capabilities.

These new services, now available at LGM Pharma’s Irvine, CA, facility, offer significant benefits to drug developers, including accelerated turnaround times, enhanced quality control, and cost savings.

In response to the increasing demand for fast and reliable testing of sterile compounds, LGM Pharma’s newly installed state-of-the-art equipment at its facility in Irvine allows for faster detection and release of drug products, especially critical for sterile injectables. Rapid sterility testing reduces incubation time by more than 50 percent, cutting the standard 14-day process to just five days.

This means drug sponsors can bring products to market faster, with strengthened confidence in quality and regulatory compliance. The new testing services also provide automated result readouts that boost data integrity and reduce the likelihood of human error.

LGM Pharma’s PCR-based sterility detection greatly improves detection throughput, shortens detection time, and augments the sensitivity and accuracy of the test, ensuring high-quality, safe drug products.

“LGM Pharma is committed to providing comprehensive services to our clients,” said Shailesh Vengurlekar, Senior Vice President of Quality and Regulatory Affairs at LGM Pharma.

“Our investment in new testing capabilities reflects our commitment to providing the highest quality services to our customers in both small and large pharmaceutical companies. Many of our clients, particularly those in the compounding pharmacy space, have been looking for a reliable partner that can deliver fast, accurate, and affordable testing for their sterile products; this expansion allows us to better serve their needs. By offering faster turnaround times and enhanced data integrity, we are helping our clients accelerate their product development and bring innovative therapies to market more efficiently,” Vengurlekar added.

Endotoxin testing and rapid sterility testing are essential components for pharmaceutical companies developing sterile and injectable products. The ability to offer these services, particularly to smaller pharma companies and compounding pharmacies, ensures that even those with limited budgets can access high-quality, reliable testing. This accessibility is especially important for companies navigating the 503(a), 503(b), and 505(b)(2) regulatory pathways, which require rigorous quality control measures to meet FDA and global regulatory standards.

"LGM Pharma's focus on quality and compliance is unwavering. Our expertise in analytical testing services ensures accurate and reliable results. Our expanded testing services ensure that our clients' products meet the rigorous standards required for regulatory approval. The new equipment and capabilities demonstrate LGM Pharma's commitment to innovation and meeting industry needs,” said Diem Hoang, Director of Quality Assurance at LGM Pharma.

By integrating endotoxin and rapid sterility testing into its service portfolio, LGM Pharma strengthens its position as a full-service provider for pharmaceutical development and manufacturing.

This expansion will ultimately help reduce the complexity of the supply chain for clients, enabling them to streamline production timelines and lower the costs associated with out-of-specification results and repeated testing.