You use it to make change happen and that is exactly what the Phorum’s leaders did after the first edition of the Biomanufacturing Technology Roadmaps in 2017.  And now they are starting to see the results.

The steering committee launched ten projects that included, among other things, prototype designs for new technology, proof of concept demonstrators and the development of guidelines on topics such as collaborative validation and industry standardization.  In all cases, the projects were chosen where industry collaboration was crucial to making progress and ultimately for the vision of the roadmaps to be realized.

Eighteen months on and some breakthrough results are starting to emerge. One example is the Plug and Play project (borne out of the Automated Facility roadmap).  The workstream arranged a workshop in November 2018 for 20 vendor and six end-user representatives. The output of the workshop proved that ‘plug and play’ was possible and demonstrated that rapid interconnectivity could be achieved between process control systems and vendor equipment.

Another example is Buffer Preparation, where the team has delivered a user-specification document for a buffer preparation skid that enables a reduction of footprint, preparation time, labor and costs. The demonstration skid is about to be built, with the support of significant funding from NIIMBL, and the test data generated will be published to accelerate commercial systems’ adoption.

Other projects include themes from across the first edition of the roadmaps, such as harvest clarification, continuous downstream processing, rapid release testing through in-line monitoring, rapid methods for adventitious detection and sterility assurance, standard facility design, big data to smart data, robotics and knowledge management.

Working together

Collaboration is crucial to the success of these projects because if a company tries to develop new technologies by itself then it can be a very uncertain and expensive process.

“Projects such as Plug and Play can only be done properly through collaboration, they can’t be done in isolation,” says BioPhorum Director Steve Jones. “Collaboration pools all the effort and reduces risk. And because everyone is working together, progress is quicker and the results are delivered sooner.”

The Phorum’s process draws together a wide range of different experts – including biomanufacturers, equipment suppliers and engineering companies – who can give a collective industry view. Bringing together these different viewpoints means the team has the best people and the best capabilities, and therefore the best chance of ensuring new technologies are developed.

Future developments

The aim over the next few years is to continue developing the above portfolio of projects and see the technologies come to market at a commercial scale.

At the same time, the steering committee has started planning for another round of technology roadmapping and has been scoping out some new strategically important themes. After conducting a ‘heat-mapping’ exercise with members, the focus will be on the priority themes of the ‘internet of things’ and digitization, new analytic technologies and diagnostics, and the whole end-to-end process from raw materials and manufacturing to the patient.

Detailed scoping and definition of these strategic themes is now underway, and by mid-2019 associated roadmapping working groups will be mobilized. Throughout this planning and development, the team will work with other Phorums to leverage their knowledge and contacts – and so enhance the existing collaborative approach to accelerate technology development and adoption.