This is a slide deck describing the implementation of a standardized, DOE-based immunoassay development process using laboratory automation: Joelsson – Rapid Assay Optimization DOE
This study was also published as an article:

J Immunol Methods. 2008 Aug 20;337(1):35-41. Epub 2008 Jun 12.
Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments.
Joelsson D, Moravec P, Troutman M, Pigeon J, DePhillips P.

Abstract:

Transferring manual ELISAs to automated platforms requires optimizing the assays for each particular robotic platform. These optimization experiments are often time consuming and difficult to perform using a traditional one-factor-at-a-time strategy. In this manuscript we describe the development of an automated process using statistical design of experiments (DOE) to quickly optimize immunoassays for precision and robustness on the Tecan EVO liquid handler. By using fractional factorials and a split-plot design, five incubation time variables and four reagent concentration variables can be optimized in a short period of time.

Thanks for reading!

Dan

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We recently published an article on the automation of a cell based potency assay for a varicella vaccine.  Here’s the citation and abstract:

Journal of Virological Methods
Volume 166, Issues 1-2, Pages 1-110 (June 2010)

Rapid automation of a cell-based assay using a modular approach: Case study of a flow-based Varicella Zoster Virus infectivity assay
Pages 1-11
Daniel Joelsson, Irina V. Gates, Diana Pacchione, Christopher J. Wang, Philip S. Bennett, Yuhua Zhang, Jennifer McMackin, Tina Frey, Kristin C. Brodbeck, Heather Baxter, Scott L. Barmat, Luca Benetti, Jean-Luc Bodmer

Abstract:

Vaccine manufacturing requires constant analytical monitoring to ensure reliable quality and a consistent safety profile of the final product. Concentration and bioactivity of active components of the vaccine are key attributes routinely evaluated throughout the manufacturing cycle and for product release and dosage. In the case of live attenuated virus vaccines, bioactivity is traditionally measured in vitro by infection of susceptible cells with the vaccine followed by quantification of virus replication, cytopathology or expression of viral markers. These assays are typically multi-day procedures that require trained technicians and constant attention. Considering the need for high volumes of testing, automation and streamlining of these assays is highly desirable. In this study, the automation and streamlining of a complex infectivity assay for Varicella Zoster Virus (VZV) containing test articles is presented. The automation procedure was completed using existing liquid handling infrastructure in a modular fashion, limiting custom-designed elements to a minimum to facilitate transposition. In addition, cellular senescence data provided an optimal population doubling range for long term, reliable assay operation at high throughput. The results presented in this study demonstrate a successful automation paradigm resulting in an eightfold increase in throughput while maintaining assay performance characteristics comparable to the original assay.

If you have any questions or comments about this article, please use the comments button and I will answer them here.

Thanks for reading,

Dan

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