BioPharma Industry Getting Comfortable With Complex Single-Use Devices

By Eric Langer, president and managing partner, BioPlan Associates, Inc.

The rate of usage of disposables in biopharmaceutical manufacturing has increased substantially over the past six years in a variety of areas, but most notably for complex devices, that are also among the most expensive. Results from our 9th Annual Report and Survey of Biopharmaceutical Manufacturers suggest that market penetration is beginning to grow for complex technologies. Because adoption of new technologies, such as single use devices, in currently approved bioproduction processes is difficult, switching to plastic single use production typically is considered for new products, not existing production.

In our study, we asked respondents which types of disposable and single-use systems they used at any stage in bioproduction (R&D through commercial production). We found that the adoption of bioreactors, which had grown only marginally from 65.2% in 2010 to 68.1% in 2011, jumped to 77.3% this year, representing ~9% year-over-year growth in adoption. Overall, bioreactor usage has now grown from 21% in 2006 to 77.3% in 2012.

Other complex systems also demonstrate rapidly growing penetration rates. This year, 72.7% of the hundreds of qualified biotherapeutic developers and CMOs we surveyed reported using mixing systems, a 33% leap from 54.8% the previous year. This is notable, given that adoption of mixing systems had remained basically unchanged from 2009, when penetration stood at 55.6%. Looking as far back as 2006, we now find that adoption of mixing systems has almost quadrupled, from 19.4% then to 72.7% now.

Relative to the above, growth of membrane adsorbers, which increased from 50.6% of respondents to 53% this year, was minimal.