Productivity in Biopharma to Increase, CPhI Report Predicts

CPhI has released the bio trends portion of its annual report, bioLive Biologicals Predications and Trends, in anticipation of the new bioLive conference, collocated with CPhI Worldwide, being held Oct. 9–11, 2018 in Madrid, Spain. The report includes commentary from industry experts Mike Ultee of Ulteemit BioConsulting and Kent Payne, CEO of Socorro Pharmaceuticals.

In the report, Ultee projects great strides being made in the next five years in the areas of cell-line productivity for recombinant proteins, fusion proteins, and enzymes. Ultee believes that the use continuous bioprocessing may spur the return of perfusion bioreactors aided by inline new filtration technologies-ultrafiltration, diafiltration, and concentration equipment. High-efficiency perfusion techniques will also enable extremely high densities (~ 10⁸ cells/mL) in small volumes. According to Ultee, the pipeline of chimeric antigen receptor T-cell and gene therapies will come to market in increasing numbers as bioprocessing techniques have proved reliable in bringing products through clinical and commercial production.

“In five-years’ time we will have been through a golden period, with game changing improvements made in upstream, downstream, and continuous bioprocessing. The market will by then also boast much greater numbers of biosimilars and new applications for cell and gene therapies. The industry is collectively maturing extremely quickly from big pharma and biosimilars to [contract development and manufacturing organizations],” added Ultee.

Demand for qualified biopharmaceutical professionals is outpacing supply, according to Kent Payne, CEO of Socorro Pharmaceuticals. Payne, therefore, believes the industry will see small-molecule professionals moving across, especially in areas such as conjugation and antibody drug conjugates, where there is directly transferable expertise. However, as biomanufacturing enters its maturation stage, especially amongst the smaller nimble biotechs, they will increasingly look to borrow from practices already established in the small-molecule segment rather than by ‘any means to market’, according to Payne.

“There are lessons to be learned from pharma peers to drive enhanced productivity and quality, whilst simultaneously lowering costs.  The processes and skills that have been honed at larger companies to drive operational excellence are key to the smaller companies’ growth and profitability prospects. As small companies reach a tipping point in their lifecycle, they must move beyond the ‘just-get-it-done-by-any-means’ mode to a ‘growth-by-design’ mode in order to be prepared for commercialization and beyond,” commented Payne. “Over the past decade or so, many of the larger biomanufacturing players have implemented more sophisticated production management systems to provide real monitoring and optimization. Nevertheless, in comparison to small-molecule counterparts, there is still much room for improvement.”

Rutger Oudejans, brand director at UBM for bioLIVE, sees these observations as evidence for the importance of events such as bioLive. “The findings in our [a]nnual [r]eport clearly support the need for introducing an event like bioLIVE-one that supports the benefits of the growing exchange of ideas across small molecule and biomanufacturing. What is most exciting is that in an age of renewed innovation and with drug attrition rates falling that we might also be able to bring these new biologics to market much cheaper. It’s one of the central themes of this year’s inaugural event, ‘how to help transition the growing workforce needed in bio’ and, of course, ‘how we can make manufacturing more efficient and bring medicine to patients faster’. The synergies we are seeing with small and large molecule in the long-term will help both industries innovate and commercialize better in the future.”

Source: CPhI