The strategic focus of debate about the long-term development of biologics manufacturing is shifting away from its traditional emphasis on stainless steel and increasingly considering the softer issues of people and technology. Avecia's Dr. Stephen Taylor now discusses that as short campaigns of ever more complex, personalized biotech-drugs become an increased part of the product mix, so technology will grow as the third challenge in biomanufacturing.
Dr. Stephen Taylor
In exploring the factors necessary to secure long-term growth of a biomanufacturing industry, the three critical requirements of assets, people and technology loom large.
In recent years most of the focus has been on 'liters of fermentation capacity' — assessment of existing capacity and that under construction with comparison to projected market need. This rather imperfect analysis, based on assumptions about clinical success of products in the global pipeline, generated concerns that lack of capacity would constrain market growth of new products. This view was largely driven by the surge in the numbers of monoclonal antibodies in development and which require very large-scale cell culture biologics capacity. However, recent emphasis in biomanufacturing has moved steadily away from measuring outright investment in stainless steel.
Essentially, this is because it is now recognized that capacity supply and demand have moved into reasonable balance. They seem likely to remain so, with a number of new and expanded manufacturing facilities in North America and Europe being brought online — albeit though there are first signs of potentially unutilized capacity. These new facilities are the result of investment decisions made in 2001 and 2002, when concerns resulting from Enbrel capacity not keeping pace with demand, with associated loss of sales, first surfaced.
Accordingly, increasing attention and media coverage have been devoted to the industry's second challenge — the current and future supply constraints of people and industry-wide competition to secure the brightest and best. The lack of skilled people able to work in biomanufacturing — and, moreover, interested and keen to do so — has been and remains a concern for almost every business either setting up or expanding existing biologics operations.
Addressing this major challenge, which is recognizable in so many science-based industries, requires long-term action across the education community and at both national and corporate business levels. In the UK, the plan to establish a national bioprocessing network that will improve interaction between the manufacturing operations of the biotech industry and the academic training and development base is to be applauded and supported.
Through this mechanism the future leaders of our industry will receive inspiration, encouragement and training by exposure to real-life business operating experience. The UK has clearly identified that if it can get the people issues right at a national level and ensure availability of high-quality staff, then business investment and growth of operations should follow. In a similar vein, the recently announced national bioprocessing training institute in Ireland is also a positive step, aimed specifically at the people challenge — and in a country that has received considerable investment in capacity but where the people challenges threaten sustainable growth.
Capacity and people are of course the big drivers, but they have perhaps tended to obscure the third challenge which is now lifting above the horizon. That is the imperative for continued investment of time, money and human inventiveness in enhanced manufacturing technologies.
In one respect, technology is an obvious part of the story. That is, in the context of the growing market and competitive pressure to reduce development timelines and ensure that when new biologics do reach the market, they are economically viable as medicines and profitable to the companies developing them. If we consider some of the conflicting demands on drug development this need is clear. These demands include:
- Global pressure on healthcare budgets is growing with the drugs bill the prime target.
- There is a growing demand in many of the poorer parts of our world for cheaper medicines.
- Many biologics are already at the edge of affordability and are recognized as expensive medicines.
- Without doubt gene discovery will continue to identify many new treatment options.
- Future medicines are almost certainly going to be more complex.....
- .....and we will all continue to demand safer medicines with no side effects.