The Wiltshire, UK-based biomanufacturer has begun working on the 530m2 building to replace older facilities and expects construction to be finished by November, with the equipment installed and the labs operational early next year.
Biopharma-Reporter.com spoke with Dr Phil Luton, commercial and marketing manager at Porton, to find out more about the site:
What is this new suite of developmental labs set to be used for?
It will be primarily used to support our two existing products, Erwinase - used to treat Acute Lymphoblastic Leukaemia - and the UK’s anthrax vaccine, but will also be used for contract development of projects that we have in our pipeline or with our customers. Obviously the latter are under confidentiality so I can’t go into detail!
What about improving biomanufacturing processes?
The new facility will undertake work such as developing and accessing new and improved methods, and or processes that can be fed into the existing processes to improve yields, or replace older technology with more modern one.
A key part of that is to provide the data/evidence that we need to assure ourselves and the regulators, so that we can then apply for license variations for products.
The site will feature a fermentation suite with a range of bench-scale reactors and a down-stream processing suite for activities such as filtration and chromatography, but what sort of technologies are you equipping these with?
With regards to single use technology or stainless steel, we do have both but are using more single use disposable technology. For example the new suite will still have a range of fermenters so that we can look to optimise growth and expression parameters, but we are also using technologies like wave bags for growing certain organisms, and then a lot more plastic consumables for the downstream processing aspects.
What benefits do the disposable elements bring?
Some of the advantages of disposable technologies are that they are essentially ‘plug and play.’ You don’t need sanitisation and sterilisation runs between experiments, and a lot of the manufacturers now provide fully validated systems, so it is easier to model and then scale processes from the development labs to the production facilities.
How will the new plant fit in with your existing network?
The facility will support our existing network by allowing us to continue to provide our expertise and knowledge to our partners/customers who want assistance to enable them to get their products to market.
We feel that not only do we have the scientific credibility of having developed many products over many years for various customers, but also that by having our own licensed products at market that we can also provide our knowledge of engineering, quality and regulatory aspects to our partners.
And finally, as a UK-based company, I have to ask, will these plans be affected by Britain’s decision to leave the European Union (EU)?
I think it is too early to speculate on the effects of Brexit.