Addressing the challenges of advanced biomanufacturing
In my latest event preview, discover what you can expect at the 4th Annual Mid-Atlantic Advanced Biomanufacturing Symposium (27—28 October, Charlottesville, VA, USA).
The 4th Annual Mid-Atlantic Advanced Biomanufacturing Symposium (27—28 October, Charlottesville, VA, USA) invites key stakeholders to discuss basic research and technology developments as well as commercialization considerations. Representatives from industry, academia and government organizations will share ongoing research, insight into clinical implementation of regenerative medicine products, and funding and regulatory concerns.
I spoke to session chairs and other speakers from this year’s event to give a sneak-peek of what attendees can expect.
What is the state of the bioscience workforce in the USA?
Russ Read (Executive Director National Center for the Biotechnology Workforce), session chair: From my perspective which is to look more at the workforce trends and necessary training especially at the technician level at least in the US, we are aware of an impending wave of change and demand for technicians, especially in the tissue engineering and biomanufacturing space. This is due to the emergence of new therapies such as those in regenerative medicine, gene and cell therapies, amongst others.
What is ARMI and how has it evolved over the last 10 years?
Jennifer Briggs Braswell (Chief Membership Officer and Chief Administrative Officer, Advanced Regenerative Manufacturing Institute (ARMI), NH, USA), session chair: ARMI was founded in December 2016 to make practical the scalable manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. We have grown from an idea to over 150 members including universities, nonprofits, and standards organizations and our focus in tissue engineering and regenerative medicine is advancing scalable, modular, automated and closed manufacturing systems to accelerate translation and commercialization of tissue engineered medical products (TEMPs).
BioFabUSA is a public-private partnership between the Department of Defense (DoD) and ARMI to attract and develop an ecosystem of both large and small companies. This includes startup companies and larger firms that see an ecosystem approach as the best way to advance manufacturing of TEMPs). The ecosystem advances ARMI’s mission by developing and enabling the technologies, predecessor products, supply chain, standards, regulatory pathways, appropriately trained workforce and commercial ecosystem necessary for scalable manufacture of engineered tissues.
Why is it important to monitor and develop the bioscience workforce?
Jennifer Briggs Braswell: The required skills for an emerging industry like biofabrication will inevitably shift over time as technologies and manufacturing platforms are implemented to improve commercialization methods in this field. There will always be a need for innovations by highly trained scientists and engineers to develop new solutions and technologies. As manufacturing capabilities mature, the need for highly skilled technicians will increase.
BioFabUSA has collected industry input on skills gaps and training needs, which will necessarily change over time as the standard practices evolve. BioFabUSA maps current educational assets to identify gaps in current education and training curricula. The information is used to provide career pathway guides for those interested in career opportunities in this field and identify opportunities for improvement.
Russ Read: It’s important to monitor and engage employers particularly in the US through our trade associations, so that we can help employers understand their workforce present and future workforce needs. Not much can be accomplished without an educated and competent workforce.
How does ARMI support the development of regenerative and other biomaterials?
Tom Bollenbach (Chief Technology Officer, ARMI): We are building the manufacturing infrastructure that facilitates the transition from a great research and development program to first in human studies and eventually to commercial scale manufacturing so that patients receive sufficient numbers of safe, effective and affordable TEMPs. The manufacturing infrastructure we are building supports every stage of the TEMP manufacturing process from harvest of a biopsy from a donor or patient to shipment of the final product back to the clinic or operating room, and consists of platform technologies enabling better culture media and reagent development, the development of TEMP-appropriate manufacturing equipment, automation, measurement and data analytics, and more systematic process development activities.
How have biomaterials developed over the last 10 years?
David F. Williams (Professor, Institute for Regenerative Medicine, Wake Forest School of Medicine, NC, USA), speaker: Biomaterials were first used in implantable medical devices and, over many years, they have been refined and improved such that a small number of highly inert, sophisticated, engineering materials provide good functionality and performance. Unfortunately, such materials are rarely appropriate for tissue engineering, where specific biological activity, rather than inertness, is required. Much attention has been placed on some synthetic biodegradable polymers, some natural polymers, such as collagen, and decellularized tissues, but so far none are ideal.
What are the advantages of combining biomaterials with other technologies, such as cell therapy or xenograft models?
Glenn Prestwich (Presidential Professor, and Director, Center for Therapeutic Biomaterials, University of Utah (UT, USA)), speaker: Biomaterials are essential as structural and physiologically supportive matrices for cell survival, health, expansion and differentiation. Getting the biology right requires getting the biomaterials right. This has only become more poignant in the last five years, and needs to be addressed from the regulatory, clinical need and business model points of view as well.
David F. Williams: Although some cell therapies are quite effective in specific areas of regenerative medicine, we usually require regenerated tissue to have volume, structure and form, which cannot usually be achieved without a biomaterial template within which the new tissue develops. The specifications for such templates, sometimes referred to as scaffolds, are complex and not fully understood as yet, but they have to support both mechanical and molecular signaling of the target cells that will express the new tissue, as well as having appropriate biocompatibility characteristics.
What are the benefits and disadvantages of using human/organic materials in the development and manufacture of biomaterials?
Glenn Prestwich: Variability, manufacturing, sourcing and regulatory hurdles are enormous. Research in the lab is fine, but it must include customer-oriented real-world perspectives from the very beginning. Amongst others, biomaterials must meet needs of end users, both patients and physicians, be easy to use by physicians and had an affordable, scalable cGMP manufacturing process.
What is the future of biotechnology development and manufacture?
Jennifer Briggs Braswell: A lesson of the last 10 years is that future manufacturing improvements will drive commercialization and expansion of the industry. In order to further develop the field, we need to attract investment. In the past, TEMP manufacturing seemed too complicated and too costly. Manufacturing improvements can drive the cost reductions needed to draw investors and more widely advance tissue engineered medical products.
Russ Read: The future is so exciting. One of my colleagues said to me, “Gosh, what a great time to be heading into this area. Don’t you wish we could be starting over again?”
Personalized medicine, breakthrough therapies are being created, unmet medical needs being attended too, all through innovation; it’ s very exciting.
Glenn Prestwich: The business models for owners of cell therapies, cell products and biomaterials patent holders must align, and the synergistic value add must be beneficial to both companies, evident to regulators, physicians and patients, and reimbursable at an appropriate rate by health care payers.
David F. Williams: Future biomaterials have to be far more sophisticated in relation to their ability to control the essential biological pathways that determine the signaling of cells in relation to the generation of new functional and viable tissues. This is also dependent on the development of new techniques to monitor the development of these functional tissues.
Tom Bollenbach: The future of biomaterials and TEMP development and manufacture are scalable, modular, automated and closed manufacturing systems, implementing appropriate in-line analytical technologies, carrying out well-characterized processes that are optimized according to Quality by Design principles.
What are you most looking forward to at the 4th Mid-Atlantic Advanced Biomanufacturing Symposium?
Russ Read: This is the first time I’m attending, but I know the organizers and we know that a next step in regenerative medicine is to build the workforce and having a panel dedicated to this discussion at the conference tells you something. It says the biomanufacturing roll out of products for regenerative medicine is upon us and we need to be ready with a well-educated and trained workforce.
Glenn Prestwich: The focus on addressing bottlenecks and challenges in manufacturing, regulatory challenges, combination products (both business and regulatory), and more. The potential for getting researchers to embrace and change their research directions based on practical real-world constraints is an absolute requirement for successful translation from bench to business to bedside.
David F. Williams: To hear whether regulators and manufacturers have compatible policies with respect to the ability to translate science into clinical and commercial success.
Tom Bollenbach: We in the regenerative medicine, biomaterials and TEMP industry are trying to solve a very complex challenge: to manufacture consistently a biomaterial or living tissue and deliver that product to patients. That challenge can only be addressed by highly diverse teams of people. The Mid-Atlantic Advanced Biomanufacturing Symposium has been a great convener of diverse organizations including industry, academia and government. When these organizations get together and share a vision for the future, great things happen.
Find out more about the 4th Annual Mid-Atlantic Advanced Biomanufacturing Symposium here>>