The prevailing view would perhaps be that the industry is not good at innovation, because it is conservative and risk averse. BPOG Director Simon Chalk shares his own views.
A MORE informed view might point to evidence in the manufacturing supply chain area, at least, that invention and innovation are happening more frequently and faster than ever before. Take manufacturing capacity, for example. In the past, if there was a need for additional capacity then the options would be either to build a new plant or go to contract manufacturing organisations (CMOs). The current problem is that new facilities take too long to build and CMOs have little inventory.
Innovative and collaborative business solutions are solving the problem. We are seeing dormant facilities on drug company sites being brought back to life in partnership with CMO expertise (Merck/MSD and Fujifilm). There are joint ventures between biopharmaceutical companies and CMOs to exploit new flexible technologies, such as single-use systems (Sanofi and Lonza), and infrastructure-ready sites are being planned where new facilities can be plugged in quickly in line with demand (GE Healthcare, Cork BioPark).
Necessity is said to be the mother of invention. Well, if it has been necessary to find novel approaches to rapidly create new installed capacity, then it is also necessary to design and develop better process technologies to drive down manufacturing cost. Payers want greater value from their spend and there is huge, unmet, market need, particularly in developing economies. Access to drugs is a prime driver for change.
The Technology Roadmap
Innovation is expensive, so priorities need to be established and resources need to be channelled into the right areas. This is being assisted by the BioPhorum Operations Group (BPOG) Technology Roadmap,(1) launched this year. More than two years’ hard work by experts from across the industry went into this programme, which is already helping to align efforts, accelerate technology developments and deliver results.
The Technology Roadmap details gaps and potential solutions across a range of capability areas: process technologies, in-line monitoring and real-time release, modular and mobile facilities, automation, knowledge management and supply partnership management. By bringing this insight into the public domain, clarity on the most important gaps enables focused application of investment, often involving cross company collaborative groups. Member companies, for instance, are now addressing technology needs through collaborative projects that may well lead to significant results for the biomanufacturing sector in the future.
Some new technologies have been in the works for some time, but have not reached widespread adoption in the commercial manufacturing environment. Pfizer is to be congratulated on its announcement to build ‘an advanced modular facility based on single-use biomanufacturing technology’ in Hangzhou, China, to supply commercial biologics locally and regionally – the first Western company to do so. Others are sure to follow – rapidly.
If the publication of a Technology Roadmap helps pull the industry forward in a concerted, focused way, then there are factors still holding it back. The complexity of the global regulatory environment is, by all accounts, getting worse. Industry consortia can only continue to work for harmonisation and regulatory innovation. BPOG’s Regulatory Interaction team continues to facilitate engagement with key health authorities and other stakeholder organisations in this space. One BPOG workstream recently demonstrated how progress could be made by meeting with ANVISA (Brazil’s health agency) to explore the vision of ‘one global submission process’. A number of practical improvements to benefit the regulators and the industry were identified.
The Digital Plant Maturity Model
The BioPhorum IT (BPIT) team has successfully developed and disseminated a Digital Plant Maturity Model, which is helping members to assess where they are on the journey to fully automated, integrated and adaptive operations. If you want to track a new trend that currently is more conceptual than reality, then ‘use of robotics in manufacturing’ would be a good topic.
Innovation must be applied to hard-edged technology and softer business processes to meet the needs of business and the market. It is also relevant and necessary when applied to attitudes and behaviour. This is clear in the Supply Partner Phorum (SPP), where suppliers and drug companies are advancing relationships through innovation to drive out non-value-adding waste from the inbound supply chain.
The key is less about novelty – and more about successful implementation of standardised approaches across the industry. Without implementation, the best innovation in the world cannot generate value.
1. www.biophorum.com/category/resources/ technology-roadmapping-resources/introduction/
By Simon Chalk, BPOG
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