LGM Pharma Boosts Testing Services with New Endotoxin & Rapid Sterility Testing Solutions

LGM Pharma, a chief provider of API and CDMO services, announced the expansion of its Analytical Testing Services (ATS) by introducing endotoxin and rapid sterility testing at its Irvine, CA facility. These new capabilities will provide remarkable benefits to drug developers, such as faster turnaround times, improved quality control, and cost savings.

To meet the rising demand for fast and reliable testing of sterile compounds, the company has installed new pioneering equipment in Irvine, which enables quicker detection and drug release products, which is crucial for sterile injectables. Rapid sterility testing now reduces the typical 14-day incubation period to just five days, which is more than 50% time reduction; this enables faster market entry with greater confidence in quality and regulatory compliance. Automated result readouts improve data integrity and minimize human error, while PCR-based detection enhances throughput, accuracy, and sensitivity, ensuring safe, high-quality drug products.

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

He further continued, “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 serve their needs better. 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.”

These services, like Endotoxin testing and rapid sterility testing, are crucial for companies developing sterile and injectable products, especially for smaller pharmaceutical companies and compounding pharmacies, to assure high-quality, reliable testing. These testing services are accessible to companies with finite budgets as these features are essential for companies navigating the 503(a), 503(b), and 505(b)2 regulatory pathways. LGM Pharma’s expanded testing capabilities support precise quality control measures required by the FDA and global regulatory bodies.

Diem Hoang, Director of Quality Assurance at LGM Pharma, said, “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.”

This addition strengthens LGM Pharma's service portfolio and its position as a full-service provider. These analytical testing services will reduce complications, simplify client supply chains, reduce production timelines, and lower testing failures & costs.