The bio-manufacturing industry continues to have problems with downstream operations, as evidenced by the 7 out of 10 (71.9%) surveyed to our 9th Annual Report and the Bio-pharmaceutical Manufacturing Survey reporting this year that they are seeing at least problems of capacity due to its downstream treatment. To evaluate the approaches adopted by industry to address these bottlenecks, we are requesting 302 bio-therapeutic developments and contract manufacturing organizations (CMOs) on the specific activities they have implemented to improve their downstream purification operations. Our results highlight some intriguing differences between how bio-therapeutic developers and CMOs have addressed these issues.
We found that a significant proportion of CMOs have used or evaluated membrane-based filtration technologies, compared with bio-therapeutic developers (63.6% vs. 38.5%, respectively). There is a similar gap between CMOs that say they have optimized operating conditions for subsequent operations.
The first two activities carried out by the CMOs are "cycling columns more frequently", "research on single-use technologies, disposable disposable technologies" and "harder negotiation with vendors" (each about 45% of respondents). CMOs are more likely than biodegraders to report on each of these activities. Although the biggest gap in these activities is in dealing more hard with vendors (45.5% of CMO vs 24.6% of biodevelopers). It is not unexpected that CMOs are also ahead when it comes to testing new technologies such as disposables.
While CMOs are testing new technologies, such as membrane-based filtration technologies or single-use systems, biodevelopers are adopting a process-based approach. For example, they are 63% more likely than CMOs to develop downstream processes with fewer steps (44.6% of biodevelopers versus 27.3% of BMCs). They are also approximately 4 times more likely to "implement the process development to shorten cycle times" (36.9% versus 9.1%) and have invested in the further development of the process.
In general, when we look at the results of CMOs and combined bio-degraders and compare them with the figures for 2011, we find that there has been a relative reduction in the emphasis on implementing activities that improve downstream purification. This may suggest that the industry is gradually moving towards a better equilibrium in its downstream capacity, and that the recent bottlenecks of purification at the bottom are beginning to diminish. This may be the result of generally improved productivity in these operations, the implementation of better process monitoring and / or improved technological adoptions.