Learning from the small molecule supply chain
It’s a key time for bio manufacturing in Europe, as larger supply chains are being built to meet new and rising demand. Thus far, as an industry, we have been pretty successful in adopting to growth in biologicals and biosimilars. But with greater numbers of BLA approvals now coming through (22 in 2017), and many others coming off patent – MAb production is forecasted to grow quickly – there remains a significant challenge for the supply chain to meet. In fact, it is my belief that this year will usher in a new age of increased integration and collaboration across the large and small molecule supply chain. There are many areas in which we can collaborate, from the obvious crossovers like ADCs (antibody drug conjugates) to the softer elements so critical to industry growth, such as supplier directories, talent, and services acquisition. For example, it’s already widely acknowledged that there is an impending bio staffing issue, with the industry struggling to bring enough experienced staff into companies. This staffing strain, at least in the short term, will probably increase and integration could help facilitate shared learning.
Growing supply options
With the bio industry now forecast by most respected observers to be growing at a mid-teens pace, put simply, more players entering the market means more supply options. But also potentially more complexity as new networks begin to appear to meet demand. It’s how we manage this complexity that will be key to maintaining the bio industry’s impressive ascent. As well as new and increased capabilities within Europe, we are also seeing an even faster predicted growth in the emerging bio economies in China, South Korea, and India. China is especially significant, as with the successful trial of the MAH (Marketing Authorisation Holder) pilot, license holders can now use a CDMO in the country – which potentially means we will see a more rapid increase in the number of bio CDMOs there. Whilst in India, companies have already been successfully producing cost-effective biosimilars, and several South-Korean companies are striving to have production-ready commercial capacity for biopharma (with some of the world’s largest production plants being completed).
So, over the next few years we will see a much larger industry, but also a much more complex one, and how partners meet in the supply chain will be key. The other consideration is that one of the main goals for the bio industry is to simultaneously lower the total cost of production and increase global capacity – which is increasingly becoming a two-tier market of large mammalian capabilities for commercial products, and single-use facilities for newer targets in the pipeline.
Quality and time has an impact
One of the key successes in the solid dose sector has been the ability for a global supply chain to come together at events to establish new partnerships and lower costs. It’s also where you are able to find the associated types analytical testing, assays, and partner services so needed to help meet changing commercial requirements. With our new bioprocessing and manufacturing event – bioLIVE – launching alongside CPhI Worldwide this year we will be creating a fully integrated sourcing hub for the industry to facilitate new partnerships.
It often said you are ‘only as good as your weakest link,’ but I believe the supply chain will be a strength that sustains its next phase of growth – providing manufacturers and product developers much greater flexibility.
(First published in European Biotechnology, Spring Edition 2018)