The upstream and downstream equipment sector has seen a flurry of consolidation over the past few years: Pall buying ATMI and Medistad, Thermo Fisher buying Life Tech and ASI, St Gobain buying Applied Bioprocess Containers, etc.
While this has led to criticism that such M&A is causing the industry to be less innovative and placing too much influence in the vendors’ hands, consolidation is set to continue, according to Scott Waniger, VP of the BioServices Division of new entity Cell Culture Company.
“As competition continues to escalate and the industry matures, more technologies are flowing from R&D to production scales,” he told Biopharma-Reporter. “The demand to consolidate infrastructure and outsource will continue to increase and drive more M&A activity.”
Hollow fiber bioreactor
Cell Culture Company is comprised of the instrument and contract service division of Biovest International, which announced it was creating the wholly-owned subsidiary this week.
And according to Waniger, his firm can hold its own among the consolidated competition through its single-use hollow fiber perfusion bioreactor tech which “meets the expressed protein needs of clients requiring less than 100kg of product per year.”
The platform enables the maintenance of cells in steady state and protein production for upwards of six months at a time, he explained, while output from the bioreactor is an expressed highly concentrated protein both cell and debris free, and ready for the first downstream processing step.
“Unlike stirred tank bioreactors, hollow fiber bioreactor systems are linearly scalable from the lab to production scale and do not require complex process development and revalidation during scale-up.”
Ongoing Challenges
While Waniger also predicted continued strong growth for mammalian cell manufacturing platforms and the growth potential for single-use bioreactors to be “robust for the next several decades,” he acknowledged there are still challenges for upstream tech vendors to address.
“As diagnostic and predictive tools become more powerful, the speed at which new cell lines and proteins are developed will increase,” he said.
“The demand to improve bioreactor optimization and control, as well as decrease operator interactions and labor hours will be just a few of the challenges. Additional challenges include reducing the cost of and time to validation as well as improving batch-to-batch reproducibility.
“These challenges, coupled with improvements in regulatory efficiency, and the increased attention to the orphan disease market - both therapeutic and companion diagnostics - will drive the need for providers to deliver platform technologies that can offer cost-effective and scalable production.”