On the roadmap again: Industry to address 'never ending' bioprocessing evolution

In July, BPOG – an industry group representing biomanufacturers, suppliers and academics – published the first edition of its biomanufacturing technology roadmap​, exploring how collaborative efforts can accelerate innovation in the bioprocessing space.

And talking at the BPI Conference – part of Biotech Week Boston – yesterday, Udayanath Aich, a principal scientist at Sanofi-Genzyme, one of the Big Biopharma collaborators at BPOG, said the roadmap has helped identify 11 areas to pool industry efforts to improve bioprocessing efficiency in light of market trends and business drivers including payer pressures, regulatory uncertainties, and new product classes.

“The 11 projects leverage pooled effort, drive standardisation, provide scale for supply partners and focus regional innovation hub efforts,”​ he told delegates.

The enabling technologies and capabilities identified in the 2017 edition cover process technologies, inline monitoring and real time release, modular and mobile functions, automated facility design, knowledge management, and supply chain management.

Each area has its own vision and expected benefits for industry. For example, plant design is addressed through a vision to establish within a year user requirements and standard facility options to respond to biologics manufacturing production needs using single-use technologies.

The project would lead to reduced factory installation time, reduced validation processes and a decreased CAPEX for manufacturers, Aich said.

“Our ultimate goal is to take the first roadmap and to implement these projects in the short, medium, and long-term across the industry​.” He added the learnings would help form part of a second roadmap, expected to be published in 2019, as “this is a never-ending process as the evolution of technology never ends.”​

Roadmap projects​

The 11 projects being addressed by BPOG are:

• Process intensification, high cell density cell culture processes
• Reliable and cost effective cell removal options for higher density processes
• Buffer preparation
• Continuous downstream processing
• Reduce release testing due to real-time release/inline monitoring
• Rapid methods for adventitious virus and mycoplasma, and new rapid sensitive sterility tests
• Standard facility design
• Data analysis, evolving from Big to Smart data
• Robotic technologies
• Product and process knowledge management across the lifecycle
• Reduction of suppliers internal testing requirements and release efforts