Traditionally, companies involved in the manufacture of biopharmaceuticals have used stainless steel components, such as holding vessels, which have to be cleaned, sterilised and validated between each batch run. Millipore believes that it is possible to replace all the key elements of the unit process with disposable materials that can reduce the cost of manufacturing and shorten the time it takes to bring drugs to market.
Millipore pioneered the use of disposable filters in pharmaceutical manufacturing in the 1970s, and there has been a gradual increase in the use of disposable components since that time. In the 1990s, HyClone and other companies started to develop disposable plastic bioprocess containers.
Now, there is a broad range of disposable products - including tubing and fittings - which means that the entire unit process operation can be carried out using disposable materials, according to Neil Holman, global product manager at Millipore.
Millipore's range of filtration and separation products cover key areas of the biopharmaceutical production process, but it has not been involved in the development of disposable bioprocess containers. HyClone brings it this capability at a stroke, and Millipore will now sell these products alongside its filters through its worldwide sales channels.
HyClone was the partner of choice for Millipore, according to Holman, because it offers the only product in the market that is truly scalable - from 50ml to 10,000 litres. This is a critical issue in biopharmaceutical production; once a drug is in Phase III clinical trials, regulations demand that there can be no change in its manufacturing process.
So where do the promised benefits of switching from stainless steel to plastic accrue? Holman told In-Pharmatechnologist.com that it is estimated that the capital costs of setting up a unit using disposable materials are 30 per cent less than a traditional, stainless steel facility, and there are dramatic time and labour savings from not having to clean and sterilise the process unit - and validate that it is truly aseptic - between runs.
"It can take six hours to clean, sterilise and validate a stainless steel unit, and just 20 minutes to replace the components using disposables," he said.
Also, once a new plant is constructed, validation can take as much as 30 months. This can be trimmed down by several months using disposable components, 'a significant benefit if you are manufacturing a drug that makes $1 million in sales a day', noted Holman.
Another important benefit is process security, and specifically the reduced risk of cross-contamination by throwing away components after use. Contract manufacturing companies are particularly interested in disposable manufacturing as they often make a number of different products on the same line.
Companies can also make more use of available factory space, as two disposable lines can be run in close proximity to each other. The cleaning required using stainless steel components - and the risk of splashing - means that these lines have to be isolated to guard against contamination.
Holman stressed that the concept of disposable manufacturing is still gaining ground in the biopharmaceutical industry, and a fully-disposable 'plastic factory' is still a long way off. For example, stainless steel housings are still needed to carry the disposable components.
While disposable processing systems received initial acceptance as cost-saving measures, he now believes the additional benefits in less down-time, enhanced process security, greater process flexibility and the capacity to facilitate greater speed-to-market will drive the sector over the next few years.
The size of the market is hard to estimate, but is probably in the order of 'a few hundred million dollars' a year at present, he said.