Defining technology strategy and leading innovation
Celebrating five years of the biomanufacturing technology roadmap
Market growth, new product groups, cost pressure, and localized manufacturing trends are significant challenges faced by the biopharmaceutical industry. They are often too great for companies to tackle on their own. To solve these challenges and lead the industry toward acceleration of technology creation and adoption, BioPhorum initiated the technology roadmap program five years ago. Looking back over the accomplishments of the Phorum during the past five years, it has made significant progress on its original mission to develop a technology management process for the biomanufacturing industry, and act as one voice of industry strategy. The vision has now been redeveloped by the next generation of industry leaders into a ‘twin’ mission:
- to create a ‘voice of the industry’ consensus that will define a technology strategy to address industry issues, influence regulators and enhance the quality of life for patients, and
- to lead innovative, collaborative teams that accelerate the creation and adoption of new technologies to solve business and process challenges.
From inception to change
Steve Jones, Director and one of BioPhorum’s founders, explained the team’s initial thoughts that led to creation of the technology roadmap. “There was a lot of frustration across the industry with the slow pace of technology innovation. We saw what was happening in the semiconductor industry, who came together collectively and developed a roadmap to drive transformation. Five years ago, we all agreed that a similar initiative was important for BioPhorum to develop for the biopharmaceutical industry.”
The Phorum has made significant progress on its initial vision. Since its inception, it has grown to ten workstreams, with 43 member companies and over 500 participants. The teams have worked diligently to create eight roadmap documents and 25 subsequent external publications and tools to identify technology targets and modeling solutions for problems facing the biopharmaceutical industry. Importantly, the roadmaps are making an impact across the industry and are the most downloaded documents in BioPhorum history, with more than 11,000 downloads to date since their launch.
Informing member strategies
Members have enjoyed significant benefits from their collaboration with BioPhorum and their contributions to the roadmaps. Josef Trapl, Head of MSci Innovation, GMS / Manufacturing Science, at Takeda Group, explained how the roadmaps have helped inform their strategies. “It is important to identify trends in the industry and determine what we should focus on. Identifying industry drivers will help us improve our manufacturing, whether it’s a new build or existing one. The technology roadmap supports us in challenging our status quo, identifying what is state of the art and what is necessary to be successful in the long term,” said Trapl.
Timo Simmen, Director Large Molecule Technology Innovation & Standardization at Janssen agreed that the vision created by the roadmap has greatly influenced Janssen’s strategy as well. “It is important to be aware of where the industry is going. Boundaries are moving and we have a great partner with BioPhorum to push ourselves and think differently. We cannot continue to simply go down the same path. In particular, our involvement in the BioPhorum technology roadmap significantly influenced our large molecule strategy roadmap. The value created by the roadmap is significant and the potential for the future is even greater,” said Simmen.
Impacting national and international industry strategy
The technology roadmap has also significantly impacted national and international strategy. Juliana Haggerty, Grand Challenge Lead at CPI explained that they speak with various funders including the UK Government, and insights from the roadmap greatly enhance their understanding of the manufacturing space and help to inform their discussions. “For example, one of the key things we are involved in is looking at innovation in the UK and as part of that we are involved in technology roadmapping sessions in the UK biopharmaceutical industry through the Medicines Manufacturing Industry Partnership, which is a key group of biopharmaceutical and life sciences industry expert groups that helps inform UK policy. By participating in BioPhorum, we can see what is missing from our national strategy and we can influence UK strategic policy decisions and spending. The knowledge we gain by being involved in BioPhorum and being able to steer ourselves in the right direction is a very useful thing for us,” explained Haggerty.
Accelerating technology collaborations
The technology roadmap has been at the forefront of fostering collaborations that create technological advancements that would not have been possible by members on their own. Simmen explained, “At Janssen, innovation is a key value driver, and we put huge efforts into it as the benefits are even greater. To be successful, it is necessary to have the capabilities and commitment to do it. But we cannot do it alone, we need to connect the dots and create a “swarm intelligence” and get success and value out of the swarm, in which supply partners, industry, and start-ups can get together and create value for our customers. Some prime examples that we have been involved in that demonstrate collaborative value are upstream and downstream optimizations, such as inline buffer, skids, robotics in fill finish, process intensification initiatives, and inline monitoring and real/right time release.” Trapl added that similar benefits have been realized at Takeda by participating in collaborative proof of concepts, which promote better technology investment decisions and allow the development of more effective facilities. “There are new technologies coming up and sometimes there are no standards. With proof of concepts, we can demonstrate that a certain standard is necessary, and we can scale them and roll them out within the organization without taking a huge risk. By being a part of BioPhorum, we can discuss proposals with our peers, determine best strategies to create further technological improvements, and benchmark internal initiatives regarding technology adoption,” said Trapl.
“Participating in BioPhorum is a unique opportunity for collaboration. We are able to create a network, achieve benefits from benchmarking, share best practices, and work on industry challenges such as creating a resilient supply chain, getting products to the market faster, and driving value as an industry for our customers and patients,” said Timo Simmen, Director Large Molecule Technology Innovation & Standardization at Janssen.
Driving improvement and innovation for the next five years
BioPhorum is proud of the workstreams’ achievements to date and is excited for what is yet to come. To ensure that the roadmap and the industry are aligned, the Phorum has conducted some benchmarking to determine where the industry is along the roadmap vision. Across the industry, progress is being made toward the value outlined in the roadmap vision in the newest facilities, with KPIs for flexibility, speed, quality, and cost benchmarked being either on track or ahead of track. Additional opportunities have been identified to improve key indicators to ensure they are relevant to the current environment, representative of a broad cross section of industry, and are continuing to point toward a consensus for long-term industry technology strategy.
Industry strategy and innovation leaders have identified their priority roadmap indicators, and benchmarked progress in their newest facilities against each measure
|KPI||#Workstream impacting KPI||2020 Status|
|Flexibility||Facility utilization (%)||5|
|Flexibility||Fed batch titer (g/L)||3|
|Flexibility||Perfusion titer range (g/L/day)||3|
|Flexibility||Product change-over (h)||2|
|Speed||Time to first GMP material (mths)||3|
|Speed||Facility build speed (yrs)||4|
|Speed||Speed to market (yrs)||2|
|Speed||Time to release product (weeks)||3|
|Quality||Cost of non-quality (% operating costs)||4|
|Cost||Total cost to supply ($/g)||3|
To drive continued success, the Phorum’s members have been focusing on their plans for the next five years. They have been actively identifying new strategies and developing next steps, including a drive toward sustainability, a focus on patient needs, and a desire to expand the scope to include end-to-end manufacturing processes that are relevant to all product modalities. A team is already in place to work on a digital technologies roadmap that aligns to these drivers. Publication of the revised vision that will allow the Phorum to address that breadth of scope is expected later in 2021. This will lead to prioritization of additional roadmapping activities and new roadmap updates. At the same time, the portfolio of proof of concept work continues to grow with two more to be initiated this year, in the field of in line monitoring and realtime release.
The Phorum has made tremendous progress over the past five years. As members’ efforts help to realize the roadmap mission – of becoming a consensus voice of the industry to innovate and drive change for the future – that progress is only set to accelerate over time.
“We have a large network in the UK, but through our participation in BioPhorum, we are able to broaden our network globally, which is a huge benefit,” said Juliana Haggerty, Grand Challenge Lead at CPI.