Homemade

Xchange newsletter - Autumn/Winter 2007/2008

Did you know that many of your Abbott assays are not only manufactured in the UK and Ireland, but were also researched and developed here too?

Our UK R&D team, based in Dartford, works together with other Abbott R&D teams around the world, including Ireland, Germany, Japan and the USA. They research new assays as well as creating replacements for those that are no longer meeting customer needs. Feedback from users is crucial as this sets the specifications for new assays [box 1]. For example, there is no point in developing a super-sensitive assay if it doesn’t measure in the correct range. The UK team also works together with ‘centres of excellence’ worldwide to obtain input from experts in various biomarker and medical fields.”

There are a significant number of variables to consider during assay research, including the microparticles to which antigens and/or antibodies are bound, conjugates, buffers, diluents, sample volume, temperature and assay protocol etc.

An Abbott principle scientist in Dartford remarked that the ARCHITECT platform’s flexibility makes a big difference when designing assays. “Unlike most analysers, ARCHITECT i2000SR allows us to choose between one-step and two-step protocols, opt for a pre-treatment step or even a delayed one-step protocol. It’s a great analyser to work on and we can embark on a project knowing that the analyser won’t let us down.”

Assays then begin a development phase where the R&D and manufacturing teams work together to optimise the assay for production. Our principal scientist for Abbott in Sligo explains, “We translate R&D manufacturing processes into sustainable factory manufacturing processes. Overall we assess the feasibility of the assay design, fine tune assay protocols and undertake validation and verification activities. Once the assay has been launched, we provide ongoing support to Abbott customers in dealing with technical queries.”

Translating customer needs into product requirements

An example of translating a customer need is as follows. A customer will typically ask for an accurate assay. Several product requirements will then be set to ensure this is achieved, including calibration with traceability to international standards (where available) and close agreement to the internationally recognised reference method. For each requirement there will be quantifiable limits, such as regression slope from 0.9 to 1.1 of reference method. These requirements are then sent to various customers for comment and revision.