Disposable components in biopharmaceutical manufacturing are continuing strong growth, especially in production areas like buffer storage and mixing systems.
This is according to BioPlan Associates’ “5th Annual Report and Survey of Biopharmaceutical Manufacturing,” in which we probed issues among 434 industry biomanufacturers and CMOs regarding their use of, and resistance to, disposables at all stages of biomanufacturing.
Since we began measuring usage in 2005, the trend has been for more usage, in more applications, with stronger expectations from vendors to provide more variety, better-tested, and less expensive products.
Some of the disposables issues covered in this year’s international study include: growth rates, disposables usage by application, newly introduced disposables, downstream operations, leachables and extractables issues, reasons for increasing use, factors for restricting use, current spending and budget growth, use in commercial-scale manufacturing, and satisfaction with vendors.
Single-use disposable components have become an increasingly common feature at biopharmaceutical facilities over the past five years. They can be used for: propagation of cell culture organisms; preparation, storage, and transfer of process solutions; the storage and transfer of intermediate or bulk product solutions; and the transfer of raw materials including media and buffers. Disposables usage has been driven largely by a need to reduce cleaning requirements and the associated time, validation, and cost factors.
Annual Growth for Disposables
In the study, we evaluated growth rates for 14 disposable applications. Figure 1 shows annual increase in market penetration (that is, market share gain, not growth rates) for the top five applications. The graph indicates the jump in the percentage of facilities now using these products.
The fastest growing acceptance for these products is in preassembled tubing sets and mixing systems. Today, there are more products available and more experience in their use. Sampling systems have matured as well, as people begin to recognize the benefits. Membrane absorbers and bioreactors reflect a trend of going to a fully disposable process.
According to Vladimir Kostyukovsky, Ph.D., senior director of manufacturing at Artisan Pharma, “What is new in bioreactors is that there are now a number of stir-tank reactors that have been tested in the last couple of years and are being more readily accepted.”
When comparing trends over the past two years, we found large jumps in a number of disposable areas including the use of membrane absorbers, which jumped 62.3 percentage points in market penetration over two years from 12.9% to 66.7% (an annual growth rate of 127%). In addition, mixing systems usage grew from 19.4% in 2005 to 73.7% in 2007 (a 54.3 percentage point increase, and an annual growth rate of 94%). Bioreactor usage grew from 21% in 2005 to 59.4% in 2007 (a growth rate of 68%).