Last year, LGM Pharma expanded its Analytical Testing Services (ATS) to meet growing demand for endotoxin and rapid sterility testing capabilities. Adding these tests under the same roof has accelerated product release while ensuring product quality and satisfying regulatory requirements, critical new capabilities for developers of sterile and injectable pharmaceuticals, including ophthalmic solutions.
The cornerstone of this progress has been platform upgrades that have enabled two advanced microbiology capabilities: endotoxin testing and rapid sterility testing. These enhancements strengthen LGM’s comprehensive suite of microbiological assays, which also include bioburden testing, Antimicrobial Effectiveness Testing (AET) and Burkholderia cepacia complex (BCC) testing.
Meeting Bioburden Standards and Regulations
One pillar of microbiological quality control is bioburden testing, a crucial step to understanding the presence of microorganisms and ensuring the effectiveness of sterility processes. FDA requires that sufficient testing for microbial enumeration and identification is performed under USP <61> and <62>. There are a range of options for testing different product types, including both sterile and non-sterile products.
Ensuring Safety with Endotoxin Testing
In addition to bioburden testing, endotoxin testing is a critical element of microbiological quality control for sterile products such as injectables and ophthalmic solutions. These assessments detect residual byproducts from microorganisms that may have been destroyed during processing, substances that pose significant risk, particularly to immuno-compromised patients. Endotoxin testing plays a key role in safeguarding drug safety and integrity by informing necessary adjustments to manufacturing processes.
Endotoxin testing is regulated under USP <85>. LGM Pharma utilizes the kinetic chromogenic method, which is a quantitative approach that measures the exact concentration of endotoxins. This method is ideal for dose-based endotoxin limits and regulatory submissions requiring precise data. By offering this advanced testing method, LGM helps ensure accurate, compliant results for manufacturers of injectable and ophthalmic products.
Rapid Sterility Testing for Faster Release
Robust sterility testing is a must-have in the development of sterile and injectable therapies. Including initiation and reporting steps, traditional sterility testing is a multi-week process, often a bottleneck for the regulatory submission – particularly the two-week testing process itself.
Access to rapid sterility testing has become a major competitive advantage. Powered by bioluminescence technology, this method enhances throughput, accuracy, and sensitivity. Since implementing rapid sterility testing in 2024, LGM Pharma has reduced testing time to just five to seven days. Faster results mean accelerated submission timelines and, ultimately, quicker patient access to critical medications. This rapid access to sterility data is especially valuable in high-demand therapeutic areas where time-to-market is paramount.
Preserving Product Integrity
Preservatives play a vital role in controlling microbial growth in pharmaceutical formulations during manufacturing and throughout a product’s use. Rigorous preservative assessment is a key component of microbiological safety testing, especially for multi-dose products, which carry a higher risk of contamination due to repeated use. In contrast, single-dose products are typically used immediately and often do not require preservatives. These preservative assessments are regulated under USP <51> and are formally known as Antimicrobial Effectiveness Testing (AET), also referred to as Preservative Effectiveness Testing (PET).
AET/PET is a 28-day test that evaluates whether preservatives in such multi-dose products can effectively inhibit or eliminate microbial contaminants introduced during use. The product is spiked with five standard microorganisms commonly found in pharmaceutical manufacturing environments. The extended duration ensures microbial growth is prevented throughout the incubation period.
Protection from BCC
Burkholderia cepacia complex (BCC) poses a particular threat to immunocompromised patients. BCC contamination during manufacturing is a risk in non-sterile aqueous products like creams and liquid formulations, including those intended for inhalation or oral or nasal use (as opposed to solid dosages). Testing to protect this vulnerable population from BCC is required under USP <60>.
Comprehensive Lifecycle Support through Reliable Partners
Full-spectrum microbiological testing is necessary for compliance with 503A and 503B compounding pharmacies as well as ANDA and NDA pathways, including 505(b)(2). Analytical support is often started as early as lab-scale and pilot batch formulation development to help identify contamination risks from raw materials, manufacturing processes, or other environmental factors.
Further testing is needed as products move into scale-up and tech transfer phases. For sterile formats, that includes testing to confirm the product remains uncontaminated across its shelf life. Upon commercialization, routine release testing and stability studies must be conducted at strategic intervals.
To ensure compliance with FDA and USP standards at every stage, companies need a dependable partner like LGM Pharma, one that upholds data integrity, maintains clear and consistent communication, offers cost-effective solutions, and conducts thorough investigations of out-of-specification results.
LGM Pharma delivers comprehensive support with rapid turnaround times, all while maintaining an unwavering commitment to quality, efficiency, and regulatory compliance.
Contact our team to learn more.