This growing emphasis on short manufacturing campaigns calls for a highly flexible manufacturing regime, characterized by
the ability to make continual fast changeovers between individual product runs that may be as low as only 2 to 3 batches per
campaign. This creates very real pressures in terms of cleaning efficiency and ultimate asset utilization, where 24/7 manufacturing
may no longer be a realistic business goal.
The scale-up and manufacturing challenges of the changing product mix notably apply to the contract manufacturing sector,
which is taking a significant and growing share of a rapidly diversifying customer base. However, if it is to truly deliver
the promise of helping the biotechnology industry bring effective, safe and affordable medicines to market — and deliver profitable
activity in the process — this sector must meet a further challenge.
Many aspects of our manufacturing processes are crying out for more innovation and with CMOs growing as the recognized leaders
in biomanufacturing, they must drive delivery, working with the regulators to help the industry through a discernable reluctance
to adopt new technologies and operating strategies.
CMOs should take the lead in creating streamlined methods for process development, building flexibility into processes to
enable effective operations across a range of scales, intensifying stages such as protein re-folding and developing innovative
procedures for fast facility turn-around between campaigns and products. Disposables technology will certainly have a place,
but with its associated high consumables, cost may not always be the best solution. Continued innovation at the interface
of science and engineering is needed and the CMO sector must rise to the leadership challenge.
While 'stainless steel' capacity issues will, periodically, re-occupy center stage in response to market forces and everyone
will seek the top talent and the right people balance, it is in process technologies that the healthcare biotech production
leaders will most likely compete for differentiation and supremacy.
It's not hard to see technology as the focus for the next real arms race in biomanufacturing. Meanwhile, we must not forget
that the ultimate aim of this strategic contest is to speed up development and contain and reduce the cost of goods because,
in the final analysis, making more and better drugs and treatments affordable for, and beneficial to, patients is the real
driver for what we do every day.
This article was first published in Contract Services Europe (November 2004, 14-17) and is reproduced with kind permission.
Dr. Stephen Taylor is the general manager at Avecia Biotechnology, P.O. Box 2, Belasis Avenue, Billingham TS23 1YN, UK, 44.1642.363.511, fax 44.1642.364.463, firstname.lastname@example.org