LGM Pharma Expands Analytical Testing Services with New Endotoxin and Rapid Sterility Testing Capabilities

—New Capabilities and State-of-the-Art Equipment at Irvine Facility Accelerates Turnaround Time and Enhances Quality Control for Sterile Compounds—

BOCA RATON, Fla., October 15, 2024–(BUSINESS WIRE)–LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, announced today the expansion of 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%, 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.”

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.

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“LGM Pharma’s focus on quality and compliance is unwavering,” said Diem Hoang, Director of Quality Assurance at LGM Pharma. “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.”

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.

To learn more about LGM Pharma’s new endotoxin and rapid sterility testing capabilities or to request a quote, contact LGM Pharma at info@lgmpharma.com or visit lgmpharma.com.

About LGM Pharma

LGM Pharma is a leading contract development and manufacturing organization (CDMO) providing comprehensive Active Pharmaceutical Ingredient (API) sourcing and drug product CDMO solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries. LGM Pharma assists clients in managing all phases of the drug product development process, from API sourcing through to commercialization. LGM Pharma’s extensive global network of qualified API partners enables clients to optimize supply chain management and distribution. Services include API sourcing and procurement, formulation development, analytical method development, method and process validation, ANDA/NDA submission, stability studies, and raw material and finished product testing and packaging. LGM Pharma is committed to quality and has a long-established positive regulatory track record, providing expert regulatory and market intelligence services to its clients. The company is focused on customer service and customized solutions, providing clients a comprehensive one-stop manufacturing solution that reduces risk, increases efficiency, and accelerates the path to commercialization. For more information, visit lgmpharma.com.

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