With the advancement of technologies such as CRISPR and CAR-T therapies, there has been a significant increase in the development and production of biologic drugs, Advanced Therapeutic Medicinal Products (ATMP) and Cell and Gene Therapies (CGT). Single-use manufacturing has provided for a large degree of flexibility in terms of production volumes but have also brought about efficiencies in sterility control by reducing hands on cleaning and sterilization necessary for stainless steel.
However, as much as the industry is working towards completely closed production systems with the advent of Restricted Access Barrier Systems (RABS) and Process Analytical Technologies (PAT), there remains critical control points that could potentially introduce contamination to a bioprocess. Whether a process scales out or scales up, there are transfer steps and human involvement that could potentially introduce adventitious agents and bacteria. During expansion, the stakes get higher and higher as the production volume increases. Whether during a media fill or during a campaign, the effects of any sterility failure are costly in terms of product, time, and person-hours.
Automated Bioprocessing Contamination Screening
While strong measures are typically in place to mitigate the risk of contamination events, there is still room for a more robust at-line surveillance system. The nature of biologics manufacturing is to grow cellular products and the environment is ideal for the growth of many microorganisms. Most show themselves early in a contamination event through a change in turbidity, pH or DO. However, there are more fastidious and slower growing organisms that may not have a noticeable impact early on in a process. These organisms do not always have a noticeable impact until much further down the process — where the stakes are much higher.
While there are lists of common contaminants of this sort, each facility and process are different and supports a unique bacterial flora. Having a screening and surveillance system that is tailored to detect common and facility or process specific organisms can increase confidence in sterility. Having the ability to screen for these contaminants quickly and accurately during and between process steps can lead to increased confidence in forward processing, further mitigating risk.
One Minute to Prepare, Two Hours to Result
LexaGene’s MiQLab Open Access System is capable of the multiplexed detection of up to 27 different targets in one simple test format. Assays can also be customized to suit individual facility needs. Sample preparation takes less than one minute using less than 1ml of sample. This rapid system provides automated results in two hours to help make more informed and confident forward process decisions.
Download our MiQLab for Bioprocessing brochure to learn more.