Is location a key factor in CMO selection for drug developers?
David Collins, Chief Commercial Officer, Symbiosis Pharmaceutical Services
There is an observable trend for increased outsourcing of small and large molecule manufacturing which is supported by the reported expansion of the CMO market, estimated to be worth about $5bn over the last 15 years. The decision to either manufacture in-house or outsource the responsibility to a contractor, is one that usually takes a fair amount of consideration, especially when factoring in the additional requirements for vendor selection. Due to the ever-increasing complexity of drug development, the selection of specialist solutions providers means that more and more sponsors are looking at offshoring with CMOs.
Traditional assessment of CMOs has centred on their ability to optimise processes and working culture but, with global options for outsourcing, there are more options available for offshoring than ever. The obvious reason for considering some potential locations for cGMP manufacturing is savings on labour comparative to Europe or the US, but leading with cost as the main factor for decision-making can have risks. Europe has a strong historical record of attracting clinical trial investment and has a well-established supporting infrastructure that provides assurances on quality and confidentiality as well as a well-established logistics and supply chain processes.
Additionally, there is substantial confidence in the regulatory compliance of UK-based CMOs thanks to the administration of the MHRA, which is widely acknowledged as the gold standard for regulation. It is also wise to consider a CMOs ability to comply with international standards such as FDA requirements for clinical manufacturing. Working with a CMO like Symbiosis which is FDA inspected, ensures that we comply with US sponsors’ quality manufacturing requirements under the Current Good Manufacturing Practice (CGMP) regulations to ensure proper design, monitoring, and controlling of manufacturing processes, facilities, and operations.
Technology as an enabler
One of the benefits in the aftermath of the global pandemic is the rise of new tools and technologies to collaborate and operate seamlessly on an international scale. The further development of the global supply chain has forged new and more resilient pathways for supporting clinical manufacturing on an international scale. This enhanced accessibility has created greater freedom of selection to international vendors, though there is still a lot to be said for the ‘human factor’ and meeting your collaborators face-to-face.
Globalisation of the pharmaceutical industry underpinned by supply chain resilience
With heightened restrictions on the import of pharmaceutical raw materials, intermediates, active ingredients and formulated products, sponsors can only be confident that their supply chain is secure when working with CMOs that have a history of successful supply chain management globally under both normal and adverse conditions. Operating regions should not impact quality as excellent logistics and supply chain management capabilities are required to ensure the security of drug product supply for customers and patients, regardless of location. Ensuring your CMO has a robust supply chain policy with contingency and resilience, including the stocking of long-lead time materials and optimising operations with smart tools can mitigate typical issues encountered by less nimble CMOs.
North America’s long-standing relationship with European CMOs
Europe continues to attract clinical trial investments; this is primarily due to long-term competitive advantages regarding the national healthcare systems, with hospitals, competencies and knowledge for conducting clinical trials. As a result, this creates a clinical supply chain opportunity for developers to work with local, European-based CMOs to expedite the production of therapeutics and get these to patients.
Scotland’s central European location and its proximity to international airports with direct flights to the U.S. and elsewhere, make it easy to feed into the global supply chain. Additionally, there is a strategic objective from the national government in Scotland to grow and develop the life sciences sector, ensuring that it has the correct infrastructure to support the sector. This means a commitment to developing and importing the best industry talent to support this vision in the form of policy, grants, funding, enterprise agencies and other enabling mechanisms.
In 2020, the UK was the second most prolific exporter of medicinal and pharmaceutical products to the US. Europe continues to perform strongly in attracting clinical trials including new therapeutic solutions, such as ATMPs and is supported by the focus on improving regulatory pathways, and the existence of leading specialist centres for investment.
The UK facilitates access to potential collaborators
The UK’s science and research capabilities are strong and have been for decades, being home to two of the world’s top five universities for life sciences. Located by major international transport hubs (London, Edinburgh and Glasgow) also facilitate connections to other collaborators in Europe and the rest of the world.
The UK also offers practical benefits, such as having English as the local language (which for a US company helps with transferability of labour) and accessibility and connectivity (with links to the academic triangle of Cambridge-Oxford-London, and direct flights possible to and from the US).
Scotland’s aspiration to be Europe’s leading cell and gene therapy development hub
Manufacturing of certain new therapeutic solutions, particularly ATMPs, is complex, high-risk, more time-sensitive, and smaller scale. Consistency of manufacturing quality is also more critical: while new drug reviews by regulators typically focus 80% on clinical factors and 20% on chemistry, manufacturing and controls (CMC), for ATMPs this ratio is reversed. There is an acute need and motivation to construct a supportive infrastructure of researchers and health innovation businesses to translate, test and nurture new ideas at scale, at pace and on time within the field of ATMPs and other progressive cell and gene therapies in Scotland.
Scotland is evolving the skill of its workforce to meet future needs: for example, there has been substantial investment in this sector and these developments will provide additional, regionally focused support to the cell and gene therapy sector to accelerate product development, clinical trials and adoption. This means the existing talent pool can be used and upskilled to meet the needs of new technologies. It is another achievement for expanding expertise in advanced therapies, one of the key health innovation pillars of our growing ecosystem.
Life sciences have undergone tremendous change in recent times, driven by both unprecedented growth and scientific complexity and as a result, CMOs have responded in kind by upskilling their manufacturing capabilities. This etching out of specialisms means that when working with more intricate formulations, the emphasis is more on capabilities & expertise rather than proximity, making location less of a factor.
Eventually, every project will require technology transfer. If a CMO is technically competent with a strong track record of tested systems, they encounter fewer issues and often solve issues arising promptly in partnership with the client.
 Karadima, S. (2022) FDI in pharmaceuticals: The state of play. Available at: https://www.pharmaceuticaltechnology.com/analysis/fdi-pharmaceuticals-state-of-play-investment/ [Accessed June 2022]