Stefan Karl, CEO, Mikrobiologisches Prüflabor, Innsbruck and Olaf Degen, director industry microbiology, Bruker Microbiology & Infection Diagnostics discuss how advanced microbial ID systems accelerate product release testing.
Bruker Microbiology
Drug development brings an inherent risk of product contamination as many active pharmaceutical ingredients (APIs) and excipients support microbial growth. Specialised microbial testing is essential to prevent bacterial and fungal contamination posing a serious threat to drug efficacy and patient safety, with the potential for painstaking, time-consuming and costly follow-up action.
The Food and Drug Administration (FDA) Enforcement Report Program reports that 40 percent of the 1,712 product recalls associated with contamination in the USA between 2012 and 2023, were the result of microbial contamination. Manufacturers in this highly regulated sector need effective microbial monitoring and contamination control strategies compliant with good manufacturing practices (GMP) – which are often outsourced to specialist laboratories.
Time challenges associated with genomic sequencing
Fast and efficient product release testing and environmental monitoring are critical. Traditional contaminant detection uses genomic sequencing - an effective but typically time and cost-intensive method. With mounting pressure to cut drug development time and cost, the industry needs a quicker and simpler solution that does not compromise data integrity.
A new approach to product release testing
A new microbial identification system implemented at the MPL, based on Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight Mass Spectrometry (MALDI-TOF MS), has brought down the time of identification testing for product release from days to minutes. Validated results are delivered from a small amount of culture using a comprehensive reference database.
It used to take anywhere between four hours and 20 hours to perform reliable identification testing for product release; more if additional sample preparation activity was needed, which could easily add one or two extra days. MPL’s new identification system has brought the process down from days to minutes – literally a few minutes per sample.
The system can also detect fungal contamination, less common than bacterial contamination, but still with a significant impact on the manufacturing process, the product, and the patient. Fungal contamination has been subject to increased scrutiny due to the potential for severe fungal disease outbreaks triggered by contaminated pharmaceuticals.
Identifying moulds and multicellular fungi presents a challenge for microbiologists, with filamentous fungi being particularly hard to identify. Many global laboratories identify fungi using manual processes which are highly subjective and inherently non-standardised. The new approach offers a standardised analysis of a wide range of fungal contaminants that minimises error, increases efficiency and allows for reliable cross-referencing with morphological and microscopic assessments.
Conclusion
New technological innovations are helping minimise the risk of contamination in the drug development process, while providing an accelerated and standardised product testing model. The move away from genomic methods provides pharma developers with fast, accurate and reproducible data to bring safe new drugs to market more quickly and cost-effectively.