Advances in Rapid Microbiology
For many years the pharmaceutical industry has discussed using new advanced rapid techniques but has been slow to adopt new methods. A number of reasons contribute to this and include the conservative nature of the industry, the lack of viable technologies, and lack of regulatory support for new methods This has recently changed, and rapid technologies are gaining both industry and regulatory support.
At Eurofins Lancaster Laboratories, we have been monitoring the state of rapid technology in the industry and within the last year have implemented new platforms to support the industry demand.
Rapid Sterility Testing and Bioburden
The compendial method for performing sterility testing has not changed in over 20 years. For sterile products, the 14-day sterility test can be the limiting factor in release and distribution of the product. This lengthy release process increases costs for the pharmaceutical company. More importantly, for products where there is a shortage or high demand, the 14-day delay has the potential to impact public health.
The Microbiology Group in Lancaster has purchased a rapid sterility system from Celsis. The Celsis system uses ATP bioluminescence to detect contaminating organisms. The system can reduce the length of test from 14 days to 4-5 days. The system is operational in both US and Irish facilities, and both sites have initiated validation projects. The system can also be utilized to perform a presence/absence screen of non-sterile products for bioburden. In addition, the Lancaster facility can provide quantitative bioburden on filterable non-sterile products utilizing the Millipore Quantum system.
Rapid Organism Identification
The Microbiology Group has utilized state-of-the-art technologies for organism identification for many years. A recent identification technology that is emerging is MALDI-TOF, and Eurofins Lancaster Laboratories has acquired a Bruker MALDI-TOF system. All organisms have unique protein patterns, and the MALDI-TOF system uses mass spectrophotometry to determine these patterns for unknown organisms, which are then compared to a data base of patterns for known organisms to determine an identification. Qualification of the system was completed in November, and the service is currently available.
Biopharmaceutical products are required to be tested for mycoplasma as part of the production and release process. The Cell and Molecular Biology Group has validated a system from Millipore that measures mycloplasma nucleic acids and provides results in 1-2 days. Recently they successfully worked with a client to validate this methodology, who received regulatory approval to use it for release of a cell therapy product.
As a contract lab, our goal is to offer our clients multiple rapid microbiology platforms to assist them in reducing turn around time and costs.