Despite limitations, particularly for commercial-scale production, single-use systems are being adopted by the biopharmaceutical sector according to Claire Scanlan, a process development scientist at EMD Millipore, who told delegates at AAPS in San Diego that manufacturers are attracted by the flexibility, efficiency and lower cost of such technologies.
Scanlan said that, for a titre of five to six grams per litre, it costs $172 to make a gram of monoclonal antibody (mAb) using a disposable system and $225 to produce the same about in a stainless steel bioreactor. The upfront investment for single-use is also much lower according to Scanlan, who said such systems cost around $25,000 less than steel, at $76,000.
She added that nowadays, 5g/l titre and a 70% yield is the standard meaning to make 100kg of a mAb takes 15 runs using a 2,000L disposable bioreactor, whereas in the 1990s it took a similar amount of runs but using a 10,000L (stainless steel) system. “Production and expression levels have doubled every one and a half years over the past 20 years,” Scanlan said.
EMD manufacture disposable systems but she told the room one of the most challenging steps in industry’s adoption of single-use was in the downstream, citing chromatography specifically, despite the availability of prepacked columns.
“One customer working with us wasn’t thrilled with using prepacked columns. They didn’t like the fact that packing was out of their control,” she said, adding there are also challenges surrounding non-standardisation of chromatography equipment.
“If something out of the realm of a standard capture protein A exchange or ion/anion exchange is used, it’s kind of hard to get those resins in these prepacked columns. Also chromatography probably has the most complex flowpath and so getting a fully disposable flowpath is quite difficult if trying to integrate it with the column itself.”
Despite this, Scanlan said the results of a study from prepacked column vendor Repligen showed the benefits using prepacked disposable columns.
“In small scale clinical manufacturing campaigns, prepacked disposable columns save about 75 hours of time and so if running multiple molecules in a facility it makes a big difference [compared to self-packed columns].”
In Aspen Brook's 6th Annual Survey of the Single-Use Bioprocessing Market published in August, drugmakers counted EMD Millipore as the fourth most popular single-use solutions for purification applications with 23% of the market, behind Pall, GE and Sartorius Stedim.