As the single-use trend continues and biomanufacturers integrate disposable bioreactors into new and existing facilities, Bristol-Myers Squibb said firms should consider equipment and plant size to avoid disruptions to operations.
“It’s not always easy to integrate a 2,000L disposable bioreactor into an area that’s already maxed out, so that what was meant to be a straight forward introduction into disposables become complicated,” said BMS’ Mairead Looby at last week’s BioProduction Congress in Dublin, Ireland.
“You would end up having to knock down walls, move out equipment you wouldn’t necessarily want to move out,” she added.
However, when increasing scale at an existing site – to 2,000L or up to 5,000L – Looby said there is more room to introduce disposable equipment, such as single-use mixers, medium buffer bags, connectors, valves and piping.
Single-use from the outset
Looby advised biopharmaceutical firms to implement disposable technologies from the beginning.
“When you’re starting off from scratch, you shouldn’t even really consider fixed equipment,” she said.
“If your cells can handle disposables – and you need to check that – there shouldn’t be a debate…the evaluation has been done, with significant benefit shown for disposables,” she added, citing decreased contamination risk.
BMS moves to single-use
According to Looby, an older BMS site in the US – the firm did not disclose its exact location – is looking to integrate single-use technologies.
“We have very limited single-use components in the process [at this site], we have fixed stainless-steel tanks and connections…it’s fairly rigid,” she said.
“In this facility, there is a lot of fixed piping, stainless steel rigid piping, we’d look to introduce much more flexible connections in the future. There is huge opportunity within that facility for us to introduce single-use,” she added.
Looby said the firm plans to replace the 5,000 stainless steel bioreactor with two 2,000L single-use bioreactors, and potentially reduce that in the future.
"With that particular process, we are looking to take it to the next level, and move it up from a 2g per litre process to a 5g per litre process, so instead of having 2 x 2,000L single-use bioreactors in the future, that would move to 1 2,000L single-use bioreactor,” she said.