Amersham Biosciences has launched a new bench-top separations system for purifying proteins, äKTApilot, which for the first time allows scientists to carry out process development right through to small-scale production using a single unit.
Product Director of Purification Systems for Amersham Biosciences, Karsten Fjarstedt, broke off from attending the PITTCON 2003 meeting in Orlando, USA, to talk to In-pharmatechnologist.com about the new product.
"The unit is broadly applicable to a whole range of biomolecules, including proteins, plasmids and antibodies, and Amersham has an ongoing collaboration with a company specialising in antibodies to investigate its utility in this setting,"said Fjarstedt.
He stressed that the product is an automated liquid chromatography system that bridges the gap between Amersham's analytical-scale protein purification systems and those intended for full-blown manufacturing purposes, with production volume ranges (milligrams to tens of grams) that suit clinical trial purposes and even small-scale manufacturing needs.
The product package is comprised of the äKTApilot separation unit that contains all the fluid-handling components, a Windows-based computer with flat-screen monitor and Amersham's UNICORN software, which is certified for use in a US Food and Drug Administration 21 CFR Part 11 and GMP-compliant environment.
Importantly, the company claims that the äKTApilot is designed to ensure microbiologically-secure production and contamination-free products; all wetted parts can be changed and cleaned, which makes switching between production projects straightforward.
At the core of the new unit is Amersham's long-established äKTAdesign pump, which produces reproducible flow and gradient formation over a wide range (from 4 to 800mL/min) - some two to three times competing units - meaning that users can run media with smaller-size particles and higher resolutions. The pump technology also offers gradient linearity over a 0 per cent-100 per cent range, in contrast to most other units which generally can manage 5 per cent -95 per cent, Fjarstedt pointed out. This level of accuracy makes it easier to identify the precise gradient for scale-up.
Another key property of äKTApilot is its use in scale-down procedures, he noted. It can be used to test changes in manufacturing processes for a much lower cost than doing so at the final-scale production level.
The combination of being a benchtop unit, fully-'sanitiseable' and using software that is fully FDA-compliant makes äKTApilot unique in the marketplace, said Fjarstedt. He noted that the price of the unit starts at around $90,000, in approximately the same bracket as rival systems from the likes of Millipore and Sepragen.