Annex 1 on the Manufacture of Sterile Medicinal Products was published by the European Commission on the 25th of August 2022 and entered into force a year later on the 25th of August 2023. It marks a significant shift towards risk management principles and the implementation of a Contamination Control Strategy (CCS).
Manufacturers are now required to develop and maintain a clear understanding of potential and actual contaminants within the production environment, including the identification of microorganisms detected in Grade C and Grade D areas. This creates additional demand for microbial identification capabilities to support finished product contamination analysis, environmental monitoring, and water analysis in the vicinity of production sites. Genetic genus and species-level identification methods such as 16S rRNA long-sequencing for bacteria and 25S rRNA for fungi, are well-established and very reliable. Eurofins BioPharma Product Testing Europe has extended its European capabilities for fast and cost-effective identification with the MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight) technology to better meet clients’ current and future needs. The MALDI-TOF creates a unique proteomic fingerprint for each organism. The fingerprint is matched against characteristic patterns in the expanding instrument library, which currently includes over 11,000 entries, covering more than 4,000 species of bacteria, yeasts, as well as 222 filamentous fungi.
The method will occasionally not deliver a satisfactory result for certain organisms. Despite these challenges however, the Eurofins BioPharma Product Testing Europe team, along with its competence centres for genotypic identification, can successfully identify the isolate within a short turnaround time. This year, MALDI-TOF technology has been incorporated at three additional Eurofins laboratories in Portsmouth (UK), Colmar (FR), and Munich (DE), increasing the total number of competent sites that house the MALDI-TOF technology to six. As such, Eurofins BioPharma Product Testing Europe can better serve clients to solve microbial identification challenges on a more local level.
With over 25 years of experience in microbial identification and a proprietary and validated database, Eurofins BioPharma Product Testing Europe has consistently delivered outstanding quality cost-effectively and with reduced turnaround times.