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New bio plant on the horizon

Posted by
Stefanos Ioannis Grammatikos, Biological Process Development
This marks a major step in the journey from our origins as a chemicals company to our destination – becoming a patient-centric global biopharma leader.

So, why have we decided to build our own BioPlant?
Today we rely on external contractors for development and manufacturing of biological products. When our new pilot plant comes on stream at the end of next year, we’ll have greater control over these crucial processes.

This will improve our agility and speed, lower our costs, as well as place us in a stronger commercial position.

A UCB-owned biologics pilot plant will put us in the driver’s seat for bioprocess development and clinical drug substance manufacturing. It will offer an invaluable source of know-how that will benefit the rapid and high-quality development of our current and future pipeline biologics.

We need a plant that matches our ambitions.

Our new plant will feature one 2,000 litre and three 400-litre production bioreactors. This can be further expanded by adding a second 2,000 litre bioreactor if required.

Location is ‘a no-Brainer’
Having decided that we needed our own BioPlant, the decision on where to put it was a no-brainer (pardon the pun). Braine is the core UCB site for development, manufacturing and launch of new products. Furthermore, we have received a lot of support from the Walloon Region which has made the investment proposition attractive.

The new plant will, naturally, require some new people. Just as importantly, current staff will need to develop engineering, technical and operational skills to be able to run the biological process on a large scale as well as to troubleshoot any problems that arise.

The plant’s operational success will also depend on a lot of support from the Braine site and the local manufacturing organisation. Everyone in Braine has a part to play in the transformation.

Here comes the science…
The kind of work we’ll be doing in Braine is going to be a lot different to classical chemical synthesis.

Working with living mammalian cells in large stainless steel vessels, maintaining sterility while performing additions, sampling and transfers from one vessel to the next during three or four weeks of processing – it will be a major challenge.

If just one bacterium enters the equipment, this can be enough to destroy the cell culture process.

Further downstream, recombinant protein purification involves a series of chromatographic and filtration steps which require diligent operation and a large number of specific buffer solutions that, if not performed accurately and cleanly, can affect the quality of the product and the yield.

In short, it’s a very complex and delicate process, and it can be less predictable than working with chemicals.

However, while embracing the potential of biopharma is challenging, it is essential. And for those of us at the centre of this new development, it’s very exciting.

This is one of those things that we choose to do, not because they are easy – but because they are hard (to borrow a phrase).

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