A two and half day workshop on Advanced Biomanufacturing is planned for July 17-20, 2014 in Talloires, France. The goal of the workshop is to build upon the outcomes generated from the prior NSF-sponsored workshop (held July 25-26, 2013 in Arlington, Virginia). This prior event included participation from academia, industry and government and the outcomes were reported in a published workshop report. A key element of this report was a set of recommendations from the participants, out of which two needs emerged. One need is to amplify on the scientific barriers in the field with more focused discussions to provide clear guidance on future directions to help the field move forward. The second need is to bring a small group together to hold more focused discussions with broader representation from European colleagues, as the initial workshop only included US colleagues. Such discussions will help identify international collaboration opportunities as well as refine roadmaps of specific needs and ideas to address the barriers in the field of Advanced Biomanufacturing. The outcomes will include the identification of challenges to overcome and opportunities to achieve maximal impact on science, scale up, jobs and economic growth and a workshop report will be generated. The workshop will be run by David Kaplan (Tufts University, david.kaplan@tufts.edu) and Jason Kelly, Ginkgobioworks, Inc. (jason@ginkgobioworks.com)
The workshop topic is significant and timely based on the rapid growth and potential impact of biomanufacturing in the US and around the world, including synthetic biology, biopolymer engineering, 3D printing, tissue engineering and many related topics. Advances in this field have the potential to return manufacturing jobs to the US and lead a scientific and technological revolution wherein sunlight, organisms, integrated synthesis and processing and novel biological approaches and ingenuity would provide alternatives to current petrochemically-derived feedstocks and processes and will also guide the development of the next generation of biomedical therapeutics, especially those based on the delivery of living cells. The scientific tools to support advanced biomanufacturing have been emerging over the past 10-15 years, empowered by advances in genomics and proteomics, cell biology, process engineering and design and systems integration. The conference program will provide a comprehensive overview of Advanced Biomanufacturing, including molecular approaches and building blocks, cellular approaches, assemblies and polymers, tissue and organ approaches, and systems integration. It will also provide insight into future challenges and opportunities and will catalyze international collaborations in this emerging area of research.
The workshop on Advanced Biomanufacturing led to general outcomes as well as specific session themes that highlight the barriers in the field. An overview is presented below. Modeling and Simulation (building predictive capabilities that address more complex biological themes, interfaces, scales/hierarchy, systems). The key is to use modeling and simulation tools at all levels; to improve efficiency in the discovery, development and manufacturing processes; to enhance the quality of final products and the process; and to help automatize towards advanced manufacturing. It was evident that the tools towards small molecule production are significantly more evolved, while those that permeate the rest of the topics were primordial at best. The impact of modeling and simulation could be significant if meaningful tools can be developed to predict functions at longer length scales (above small molecules) and with better feedback in process designs and control. The role of data analytics in biomanufacturing was also discussed, particularly as it relates to complex biological systems. Through semantic approaches, it may be possible to predict information that exists within gaps in knowledge, and together with advanced simulation techniques, such information can be used to propose biomanufacturing strategies. Tissue Engineering/Regenerative Medicine (the barriers depend on the application – thus discussions included topics such as cellular/acellular approaches, factoring in regulatory issues, design complexity, component/system maturity in vitro prior to utility in vivo, measurements to assess outcomes) – Issues that were raised include cells, biopolymer matrices, bioreactors and tissue designs (e.g., bringing together cells, scaffolds, growth factors). Depending on the goal, these cells, matrices and tissue systems (cellular or acellular), will be impacted by decisions based on utility, regulatory barriers and standardization. Emerging regulations in Japan suggested some new avenues towards commercial opportunities, thus biomanufacturing of such systems may become even more urgent. Foundries and Standardization Tools (enzymes, stem cells, biomaterials, extracellular matrix features, inflammatory components, bioreactors were discussed in the context of a ‘foundry’ to streamline approaches, make components available to the broader community, and to improve manufacturing and quality control. The concept was based on the approaches pursued in recent years with synthetic biology). Topics of discussion include: what is needed, how to develop efficient functional screens, interfacing imaging/noninvasive assessments for real time readouts, building in the identification of early failures to save resources and related topics. All levels of inputs to these and other components above were considered in need of a ‘foundry’ approach. Such an approach offers a collective effort towards a common goal, while providing the tools, resources and building blocks to the broader community – academic, industrial and government. Education (as new models will be needed, discussions were held to consider at what level efforts should be directed (e.g., undergraduate, graduate), joint efforts among countries (such as summer teaching options) and undergraduate senior design projects). Undergraduate senior design projects in the field of Advanced Biomanufacturing were given some focus as a suitable starting point for engaging students early on towards the needs in the field. Graduate programs were cited, such as the initiatives in Europe, for further guidance on what may work. Programs directed at faculty were also felt to be important. The workshop participants are in a position to help crystallize these ideas as the field progresses, bringing in scientists, educators and others to coalesce and refine the options. Dissemination (the need for focal points of effort to maintain communication for the field of Advanced Biomanufacturing) - Possible outcomes would include working groups that focus on selective topics, such as the Foundries above, or education needs. The formation of a society to provide a nucleus for the field or the formation of a subgroup within existing societies would facilitate this need. This has been initiated via the Biomedical Engineering Society (BMES), and can perhaps serve as the nucleus. Follow up workshops with additional focus, new inputs to journals and related venues may also be useful. IP models (a major challenge to the Foundry concept) – Input on what works, what is required to have this approach work better and new models will be needed. The issue of intellectual property, sharing materials and related topics permeated the discussions. While this was considered a major barrier, it was also out of the scope of the workshop and attendees did not focus on the issue. This would be a suitable topic for a focused workshop in the future, to begin to evolve a model that might work for the Foundry concept, with input from scientists, current Foundries, government officials, and patent attorneys.
