DOE:Layout 1 14/1/10 19:54 Page 50
Assays
References
estimates, effect sizes and response characteristics, in fully integrated approach (ie one which seamlessly
1 DOE in Assay Development both tabular and graphical form. interfaces the DOE software package, with an
Trends 2009 Report, published
Response/desirability profiling allows users to opti- automated liquid handler and the biological assay
by HTStec Limited,
mise across multiple competing response variables, set-up and subsequent readout) that is simple to
Cambridge, UK, July 2009.
2 Taylor, Paul. Optimizing
with user-defined desirability profiles for each implement clearly would be beneficial. There exists
assays for automated
response variable. In addition to the standard set of a market opportunity for a provider of an auto-
platforms. Modern Drug designs supported by most DOE software, STATISTI- mated liquid handling workstation that can be
Discovery, December 2002,
CA also provides much more versatile analytical directly interfaced with a microplate reader to
37-39.
capabilities via general/generalised linear models, combine its technology and expertise with a DOE
3 Voisard, Damien. Application
of a high-throughput semi-
variance components and other analytical and graph- software vendor to develop a turnkey solution that
automated platform for cell
ical functions, allowing users to handle a much wider fully supports DOE for AD. That platform ideally
culture media optimization. range of designs and response types. Beyond these should offer software that directly links the statis-
Presented at San Francisco
capabilities lie virtually unlimited expansion options tical design with the automated liquid handler pro-
ACS meeting, September 2006.
into more advanced multivariate modelling and data gramming and also feeds the assay readout direct-
4 Ho, Samuel et al (2009). The
Use of the Formulatrix
mining methods with enterprise-class deployment of ly into the statistical analysis package, to suggest
Formulator™34 for Design of
predictive models and web-based client-server opera- and facilitate further iterative retesting. Arguably
Experiment Approaches. tion (Figure 18). until this happens the solutions/tools on offer will
Poster Presented at 15th
at best be piecemeal components that only partial-
Annual SBS Meeting Lille,
Conclusions ly address the problem and will inevitably repre-
France April 26-30, 2009.
5 International Conference on
What is immediately apparent from this review is sent a compromise. Beckman Coulter’s AAO mod-
Harmonisation (ICH); Draft
that only one liquid handling vendor (Beckman) ule for the Biomek FX, and now for the
Guidance: Q8(R1) currently offers any application specific software BioRAPTR, must be congratulated on coming
Pharmaceutical Development
or support for investigating DOE. It should be stat- close to meeting user expectations for a DOE solu-
Revision 1 see
ed that all other established liquid handling ven- tion; however, it only accepts DOE design table
http://www.fda.gov/cber/ich/ich
guid.htm.
dors contacted when writing this review indicated input from some third party software and statisti-
they had nothing to contribute to the article. cal analysis of the assay readout is not addressed.
Although several new entrants to the liquid hand- Until new and more comprehensive ‘total’ solu-
ing market (Formulatrix and HP) appear to be tions emerge, the full impact of DOE on AD is
developing solutions with novel and enabling dis- unlikely to be realised. DDW
pensing capabilities which could be advantageous-
ly deployed for some aspects of DOE, neither has
so far launched products specifically focused on
this application, so it is too early to say what each
may contribute. Conversely, there are a number of
vendors (Minitab, MKS Umetrics, SAS, Stat-Ease,
StatSoft) that offer standalone DOE software
packages. For the most part these are generic offer-
ings that were not written specifically with biolog-
ical applications in mind, and they vary in their
suitability for assay development. What is notice- Dr John Comley is Managing Director of HTStec
able from the software vendor snapshots is that Limited, an independent market research consul-
none actually mentions interfacing statistical tancy whose focus is on assisting clients delivering
design with setting up assays and the associated novel enabling platform technologies (liquid han-
liquid handling. Herein lies the assay development dling, laboratory automation, detection instrumen-
biologists dilemma: limited automated liquid han- tation and assay reagent technologies) to drug dis-
dling tools are available that can be simply pro- covery and the life sciences. Since its formation six
grammed to perform full factorial analysis over a years ago, HTStec has published more than 50 mar-
wide dynamic volumetric range. While available, ket reports on drug discovery technologies and Dr
DOE software, for all its sophistication and com- Comley has authored 30 review articles in Drug
plex statistical analysis, is not entirely suited to Discovery World. Further information on accessing
their needs nor does it seamlessly interface with the the market report DOE in Assay Development
liquid handling instruments they need to use to set Trends can be obtained by visiting
www.htstec.com
up experiments to investigate assay variables. or by emailing
john.comley@htstec.com to receive a
The need the make DOE simpler to implement free copy of the Report’s Executive Summary and
was a major take home message from the survey. A Table of Contents.
50 Drug Discovery World Winter 2009/10
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