The Disease? Not On My Farm! ambassadors visited MSD Animal Health’s vaccine manufacturing facility, Milton Keynes, to gain a greater understanding of what it takes to bring products to market.
The Disease? Not On My Farm! ambassadors were given a tour of MSD Animal Health’s site where a number of different vaccines are made.
Locky McIntosh, MSD Animal Health production manager, explained a little about the process: “In some ways making a vaccine is still very much an ‘old school’ fermentation process; very similar to making home brew.
“It is easy to grow bacteria. What is hard is growing a quantity in such a sterile environment.
“For us that is the biggest challenge. Producing large quantities of vaccine and maintaining such a high level of biosecurity is hugely expensive.”
The vaccine production process starts with a very small 1-2ml seed culture of a specific antigen of live bacteria which is then multiplied. Depending on which vaccine is being produced, this can take anything from five hours to five days.
It then goes through a downstream process to concentrate the antigen and clean it, removing any unwanted material to leave a pure concentrated inactivated cell mass.
This is then multiplied again and, depending of the type of vaccine being produced, with either single or multiple antigens, to produce the final multi-dose vaccine.
Each batch then has to go through a vigorous testing procedure for efficacy and safety, which can take up to six months. The whole process of making a vaccine can take up to 12 months.
Stocks of antigens are sometimes held at the intermediate stage to speed up the process if additional stock is needed, but a sudden upsurge in demand for a particular vaccine cannot always be met due to the length of time it takes to produce each batch.
MSD Animal Health produces vaccines which are sold in more than 30 countries worldwide, all of which have specific labelling requirements. The same batch of vaccine may need to be labelled in several different ways for different markets.
To streamline this process, all vaccines are sent to a central labelling facility in Spain, then redistributed to the country where they are to be sold.
Mr McIntosh said: “The basic principles of making a vaccine remain the same as they always have, but the processes and equipment around it are constantly being refined and improved.
“We are always striving to make use of the latest technology to improve the product as well as making it more cost effective to produce, but the priority is to ensure the safety and efficacy of the vaccine.
“There is also a huge amount of compliance, quality assurance and quality control surrounding producing a vaccine.
“In addition to this it requires a significant amount of investment up front into the research and development of a new vaccine and it can take five to 10 years before production can begin.”
Fiona Skeen is no stranger to a laboratory environment, having studied natural sciences at Durham University, but she admits to being very impressed by the level of biosecurity at the site.
She said: “I expected biosecurity to be strict and knew we would have to wear protective clothing, but right from the start, even getting into the building security was very high and, once inside, moving between each section required changing each time.
“The process of making the vaccine was more or less what I had anticipated and, I thought, not dissimilar to distilling alcohol, such as when producing whiskey.
“The whole tour has beenfascinating. As a great advocate of using vaccines, I always take the ‘prevention is better than cure’ approach. It has given me an insight into everything involved in the manufacture.
“Something which surprised me was the fact the vaccines go to Spain for labelling, which makes me wonder what will happen after Brexit.”
Fraser Jones was surprised by the extent of biosecurity at the site.
He said: “I did not expect to have to change between each section; it took biosecurity to a whole new level.
“I was not aware of the time it takes to make a vaccine. It is a very long process and it helped to explain why there is sometimes a shortage of a particular vaccine if something goes wrong with a batch or if demand rises.
“Something which surprised me was they are still using the same strains of bacteria to start the vaccines which they relied on years ago. I had assumed these would have changed over the years.
“There are a huge number of people involved in the whole process, which is extremely closelyregulated. It felt a bit like something out of a science fiction film at times.
"I do use a lot of vaccines, so it has given me a far better understanding of them and the cost of production.”
The complexity of the facilities left a lasting impression on James Robinson.
He said: “I expected the vaccines to be produced in one big area where you could see what happened from start to finish, whereas it was a whole series of different parts completely separate from each other with strict biosecurity measures in place between them.
“It made me realise the vaccines are being made to such an A1 gold standard with so much care taken over how they are produced. Then their efficacy can be compromised by farmers if we do not take the same care in handling them.
“It reinforced to me just how fragile vaccines are. They must be handled, stored and administered correctly to be effective. It made me more aware of how important it is to follow instructions.
“I now understand that only one batch of each vaccine is made at a time, so if there is a problem with it, it cannot quickly be replaced because of the time it takes and the fact the production system will have moved onto a different type of vaccine.
“One of the most valuable parts of the visit was meeting the other farmer ambassadors and chatting to them. It made me realise that although we are farming in very different systems, we still face the same challenges.”
The enthusiasm and commitment of the people working on making the vaccine impressed Ian Alderson.
He said: “The people who showed us round and explained what was happening were really passionate about what they were doing.
“At times we had to slow them down and get them to explain in simple terms what they meant, but it was fascinating.
“I was surprised by the amount of travelling the vaccine does at various stages with the starter bacteria being brought from abroad, then the finished product labelled abroad.
“It seemed to me there was quite a bit of risk involved and the potential for things to go wrong, but this perhaps explains why at times there is a shortage of vaccine.
“I was surprised the whole process starts off with such a tiny amount of bacteria which can then be multiplied up to make such a large amount of vaccine. The whole process is very complex; it made me realise we should not take vaccines for granted.”
This article is part of a ‘Disease? Not On My Farm!’ series which showcases proactive beef and dairy farmers taking pride in their robust herd health and disease management approach.
This information was provided by MSD Animal Health, makers of Bovilis® BVD, Bovilis® IBR Marker Live, Bovilis® IBR Marker Inac, Leptavoid™ H, Rotavec® Corona, Halocur®, Bovilis® Bovipast RSP,
Bovilis® Huskvac and Bovilis® Ringvac. Always use medicines responsibly. More information is available from Intervet UK Ltd trading as MSD Animal Health. Registered office Walton Manor, Walton,
Milton Keynes MK7 7AJ, UK. Registered in England & Wales no. 946942.