"The availability of disposable equipment is allowing CMOs to change their business model," Joseph Dallapiazza, director of single use systems at Pall, told Outsourcing-Pharma.com.
"It allows them to operate 'flexfactories,' where production can be easily set up according to the different needs of each client and then discarded after each batch."
The alternative is that the CMO has to invest in stainless steel equipment dedicated to a single client, as well as clean and validate the equipment for each new batch and new drug being produced in order to avoid cross-contamination, and this is expensive and limits the amount of space and time available to deal with multiple contracts, he said.
According to Dallapiazza, It takes only weeks to set up a disposable system, whereas it can take months to a year to design and set up a stainless steel system, which has to be custom-made.
It then takes approximately four months to develop the first cleaning and validation procedure, after which point it takes one day between each subsequent change in batch or drug being produced.
Around 50 per cent of Pall's single-use technology customers are now CMOs and vaccine makers are currently the biggest users: "Vaccine producers are under a lot of pressure, both time and capacity-wise, and also need to be flexible in the scale of operation," he said.
CMOs on the west coast of the US are currently the firm's largest cluster of customers.
"There is a huge potential for us to gain a lot more business from biopharmaceutical CMOs in the future as this part of the CMO market is still in its infancy," said Dallapiazza.
Meanwhile, Pall exerted a heavy presence at the recent Interphex trade show in New York where it was promoting a bolstered product line following the addition of a number of new disposable products to its portfolio.