The report focuses on the way that biopharma companies’ pipelines are now filled with large molecule drugs, including an increasing number of personalized and orphan disease products, which have driven the use of these new technologies. The shift has also occurred as a number of these new products require limited production runs and highly specific manufacturing requirements.
The shift to more advanced manufacturing technologies is also driving companies to seek increasingly specialized workers, some of whom emerge from specially designed training programs at university-based biomanufacturing centers.
In addition, the changes are “causing biopharma companies to work collaboratively on manufacturing innovation through partnerships with academic institutions, diagnostics developers, production equipment manufacturers, and medical device manufacturers,” the report says, noting that location and ecosystem advantages are also becoming strategic.
Continuous Manufacturing
The report delves into some more of the specifics around the new technologies, particularly with continuous manufacturing, where “few, if any,” companies have announced the use of a fully continuous bioprocessing system in commercial production.
As the FDA has recently called on companies to begin the switch from batch to continuous manufacturing, the report notes that at least 12 products manufactured with perfusion or similar technologies are on the market. Meanwhile, companies such as Bayer and Genzyme have been using continuous perfusion technology in the fermentation phase of upstream processing for the past two decades.
“The potential advantages of continuous manufacturing are impressive,” the report says, “Continuous systems are much smaller in size than batch systems, thus they can produce as much or as little product as needed. Furthermore, smaller vessel sizes require fewer and less complex setup cycles. As a result, limited scale-up from clinical manufacturing is necessary (i.e., resulting in commercial scale production during clinical development), which implies faster time to market and could reduce the potential for drug shortages.”
Deloitte also calls out the challenges related to continuous manufacturing.
“First, continuous manufacturing technology development is in direct competition with long-term investments in existing batch manufacturing sites, so the industry has been slow to move away from batch manufacturing. Second, continuous manufacturing poses a challenge of how to define a batch for the purposes of quality control, for example, in cases of product recall. As a result, continuous manufacturing requires new methods of measuring quality and gathering metrics. Third, continuous manufacturing may not be ideal for low-volume, high-value products, as the amount of product lost in starting up, reaching steady state, and change overs or shut downs can have significant value.”
The report also highlights other investments made by manufacturers, including their “significantly increased use of disposable media bags and bioreactors in the upstream activities of cell culture and media and buffer mixing.”
Companies also over the past two years have employed single-use technology in downstream processes such as filtration and chromatography and in ancillary equipment such as connectors, tubing and sensors.