LGM Pharma has expanded its analytical testing services (ATS) with novel endotoxin and rapid sterility testing capabilities.
These services will now be available at LGM's Irvine, CA facility, and aim to accelerate turnaround times while enahncing quality control and saving funds.
The company has expanded its analytical offerings owing to the rapidly increasing demand for fast and reliable sterile compound testing — which is especially important for the sterile injectable market.
According to the CDMO, rapid sterility testing reduces incubation time by more than half; this reduces the process from 14 to 5 days.
Rapid sterility testing can facilitate the accelerated entry of drug products to the market, while also ensuring an injectable is of a high quality and globally compliant.
The PCR-based sterility detection service can also
- Improve detection throughput
- Shorten detection time
- Augment the sensitivity and accuracy of the test
- Ensure the safety and quality of a drug product
The service is also marketed as affordable, so smaller pharma companies with limited budgets can also access testing.
In addition to their competitive price point, the services will allow companies to navigate the 503(a), 503(b) and 505(b)(2) regulatory pathways, which need to be adhered to to meet both FDA and global regulatory standards.
Senior Vice President of Quality and Regulatory Affairs at LGM Pharma, Shailesh Vengurlekar, commented: “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.”
