GE Healthcare is taking to the road for a European tour in a specially designed truck kitted out with a complete suite of flexible, single-use products configured for vaccine or MAb production.
As well as functioning as a mobile showroom, the ReadyToRock Tour also offers an opportunity to consult one-on-one with specialists and listen to informative sessions on single-use applications and process design considerations. The presentations will cover many of the important aspects to consider when implementing ready-to-use, single-use systems, including regulatory aspects, validation of single-use products in biopharmaceutical production, integration of single-use solutions into a cGMP environment, leachables and extractables, and environmental impact.
The tour is making around 60 stops in more than a dozen countries over a period of six months, starting in Sweden and culminating in a visit to Achema in June. A schedule of the tour and registration details can be found on the ReadyToRock website. It will then move on to the US from September to Christmas, where it will visit a further 60 destinations.
With the increasing potency of drugs and the growth in personalised medicines, the single-use route to biotech manufacturing offers several key advantages, according to GE Healthcare. It eliminates cleaning requirements, thereby increasing the speed of campaign turnaround; it reduces the risk of cross-contamination; cuts the time to market because of shorter lead times; reduces validation time and costs; and requires much lower capital expenditure.
The effect, the company says, is to reduce the cost of goods by 30%, increase throughput by 20-30%, cut turnaround time by 92%, yield energy savings of 43% and result in a 35% reduction in the carbon footprint.
GE Healthcare’s ReadyToProcess equipment on board the ReadytoRock truck includes:
WAVE Bioreactor – a cell culture instrument for the production of recombinant proteins in mammalian and insect cell lines over a wide volume range from 50ml up to 500 litres, and suitable for seed train and cGMP commercial production.
Cellbag Bioreactor – a presterilised plastic bag that forms a disposable cell cultivation chamber. It is available in different sizes, for both standard and customised configurations.
WAVEPOD II – an integrated controller enabling accurate and quick regulation of the cell culture parameters. Reliable and accurate control of pH is ensured by the ‘in-the-bag’ integrated optical pH sensor.
WAVE Mixer – optimised for efficient mixing and dispersion of up to 35 litres of liquid. Functions include thawing, pooling, mixing, media and buffer preparation. A screw cap port allows powders or other solids to be easily poured into the bag, and a probe to measure pH to be inserted.
ReadyToProcess Hollow Fibre cartridges – preconditioned for cross flow filtration, minimising preparation steps and eliminating cleaning and cleaning validation.
ReadyToProcess Normal Flow Capsule filters – preconditioned for laboratory through process-scale applications and providing sterilising grade filtration for a wide range of biopharmaceutical solutions.
ReadyKart mobile processing stations – flexible design with removable and re-positionable holders, trays, bins, and shelves for organising bags and associated tubing,
ReadyToProcess chromatography columns – currently available with a range of BioProcess media in four different sizes: 1, 2.5, 10 and 20 litres. The columns offer the possibility to work in a fully flexible mode in early clinical phases while keeping a conventional reuse option for large-scale manufacturing open.
