Increasing the biosafety of analytical systems in the clinical laboratory

Truchaud, A.; Schnipelsky, Paul; Pardue, Harry L.; Place, J.; Ozawa, Kyoichi

doi:10.1016/0009-8981(94)90113-9

Cited by 9 publications

(1 citation statement)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Multifactorial parameter interactions throughout each manufacturing process are often difficult to profile using conventional lab‐scale experiments, due to limited throughput and the lengthy time cycles of production for some viruses. Further, many live virus production processes are subject to higher levels of biosafety handling procedures that require more intensive decontamination, isolation, and waste handling protocols, complicating the application of lab automation devices, such as liquid handling systems . Finally, product quality assessment for live viruses often requires panels of multiple assays, such as plaque potency and ELISA that are generally difficult to apply to high‐throughput studies with large numbers of samples.…”

Section: Introductionmentioning

confidence: 99%

An integrated robotic system for high‐throughput process development of cell and virus culture conditions: Application to biosafety level 2 live virus vaccines

Daniels

Rodriguez

Lim

et al. 2015

Engineering in Life Sciences

View full text Add to dashboard Cite

Live virus vaccines are a critical component of worldwide vaccination strategy for reducing disease burden but often require complex biological production processes that are sensitive to many different factors, both known and often unknown. Prior application of high‐throughput process development (HTPD) approaches to these processes has been hampered by a complex design space, low‐throughput analytics, and challenges inherent in biosafety level 2 containment and asepsis in laboratory automation. In 2013, we initiated a project with HighRes Biosolutions to design and install an integrated high‐throughput screening platform to enable HTPD for biosafety level 2 upstream process development studies. The system incorporates the necessary tools for performing cell and virus culture studies in microplates, as well as advanced analytical capabilities necessary for assessment of cell phenotype, product quality, and antigen yield. To date, we have applied this system to screen optimal media formulations and viral production conditions in support of two viral vaccine programs, with phenotypic assays performed as an integrated part of the workflow. This case study illustrates the power of HTPD in addressing large‐scale biological screening challenges by narrowing a vast design space and identifying parameter interactions in live virus production processes.

show abstract

Section: Introductionmentioning

confidence: 99%