Are Pre-Packed Disposable Chromatography Columns the Future for Biomanufacturers?

Pre-packed disposable chromatography columns have been steadily growing in popularity over the past several years amongst Biopharmaceutical Manufacturers. The reasons for this movement is largely due to the improvements in upstream proficiency, which in turn is causing blockages further downstream.

As a result, biopharmaceutical companies have been looking for alternative methods to hasten downstream processing, one of which is single-use pre-packed chromatography columns.

What Advantages do Pre-Packed Disposable Columns Offer?

Interest is growing in pre-packed columns not only due to the demand for alternative processing methods, but for the myriad of advantages that such columns offer. Firstly, because they are pre-packed, they are incredibly easy to set up, validate and clean, reducing the amount of labour necessary and the amount of time needed to be invested in their maintenance and use.

They allow for more runs and are simple to change over, which means increased productivity and less down-time. Furthermore, the outsourcing of non-core work will no longer be necessary, since they will come pre-packed and will be designated for single-use only. Because of this, there will also be no need for expert specialists or specialised equipment, which is often a concern in smaller laboratories.

What Disadvantages do Pre-Packed Disposable Columns Have?

Currently, the resins which go into pre-packed columns are very costly, and as such very few columns are actually intended for single use. However, the cost of such resins is predicted to drop in the coming years, and as it does so, the convenience and practicality of single-use columns will make them increasingly attractive.

Similarly, the market for such columns is currently being held back by the fact that only smaller columns are commercially available (typically under 30cm). However, as with the price of resins, this problem is expected to only be a temporary concern as research into developing larger-scale columns progresses and the production of them becomes more widespread and commercially viable.

The Projected Growth of Pre-Packed Disposable Columns

In 2010, just 1% of the biopharmaceutical industry was using or considered using pre-packed columns (as found by GEN’s Annual Report and Survey of Biopharmaceutical Manufacturing). Today, that figure has risen dramatically to 27% of the market. Standing at a current net worth of $45m-$55m (including all resins, products and services associated with pre-packed columns), the market is expected to grow 10-15% in the current year and up to 20% by 2016, making for a projected market of around $54m-$66m. As the cost of resins decreases and the viability of larger-sized column production increases, they will become more and more popular with contract manufacturing organisations (CMOs) and clinical trial facilities, thus expanding the market as a whole.

If you enjoyed this forward-thinking article, you may also like to look back at the history of LC-MS – a journey which started over 20 years again – with this article, The Fascinating History of the Development of LC-MS - A Personal Perspective.