Rapid At-Line Screening Solution for Microbial Contamination Control
Ensuring Quality and Safety
Control of microbial contamination is critical to ensuring product safety and quality. The introduction of adventitious agents such as bacteria, mycoplasma and viruses into bioprocessing can arise from several sources such as cell substrates, equipment, raw materials and operators. Contamination events can have devastating impacts on time, money, facility resources and potentially patient health if not caught early. Early and rapid screening for adventitious agents that are specific to a particular process or facility can provide higher confidence of quality and conformity or can act as an early warning of a potential quality event allowing for quicker mitigation efforts to take place.
Risk Mitigation and Evidence-Based Decision-Making
Although traditional product release is bound by growth-based testing, rapid screening methods can improve forward processing decisions. Fastidious or difficult-to-detect organisms may not be identified until further downstream or during release testing. Rapid at-line screening for causative agents of contamination failures mitigates forward processing risk and executed at various process steps complements a robust QbD and PAT strategy for newer Advanced Therapy Medicinal Products (ATMP).
A Faster, Reliable Solution
LexaGene’s MiQLab is a rapid, easy to use, sample-to-answer microbial detection system that provides accurate results for up to 27 targets including microorganisms and other associated molecular markers from a single sample. It does not require specialized personnel, laboratory space, or sample preparation and can be used to screen for contamination at multiple points from upstream culture and growth through downstream purification, separation, and filling.
For more information on our bioprocessing solutions – please visit this webpage: Biologics Manufacturing
Download our MiQLab for Bioprocessing Sell Sheet for full specifications.
