For more than a decade, team members of Watertown, Mass.-based Arranta Bio have been studying the physical and functional characteristics of Live Biotherapeutic Products.
For more than a decade, team members of Watertown, Mass.-based Arranta Bio have been studying the physical and functional characteristics of Live Biotherapeutic Products (LBPs), defined by the U.S. Food and Drug Administration (FDA) as live microorganisms, such as bacteria or yeast, that are used for the prevention, treatment or cure of a disease or condition.
Early on, the team, led by Aaron Cowley, Ph.D., Arranta Bio’s chief scientific officer, recognized not only the clinical potential of LBPs, but also the complexity involved in developing large-scale robust manufacturing processes for LBPs and, more specifically, the analytical techniques required to confirm acceptable product quality and safety for them.
With relatively few companies dabbling in the industry, expertise and CMC regulatory guideposts were few and far between.
Currently, no LBP products have been approved for commercial use by the FDA, but the drive to support clients as they forge a path to commercialization of LBP clinical therapies is ingrained in the company’s mission: Arranta, which is Gaelic for “bold,” is approaching LBP development and regulatory pathways with a bold and daring spirit of innovation.
“To be successful in this space, we have to innovate our own approaches in process development, manufacturing and analytical testing of microbiome-based products,” Cowley said. “The characteristics and requirements of LBP processing are unique, and need equally unique assays.”
“Current assays are not always the most precise. Furthermore, execution of many of the traditional microbiological-based assays is time consuming, providing answers in days, as opposed to hours,” Jeff Heiser, Head of Quality Control and Analytical Development at Arranta, explained to BioSpace in an interview.
Having gained experience with fastidious microbes, consortium-based products and genetically engineered strains over the last ten years, Heiser said the Arranta team has a keen understanding of the physical, chemical and molecular characteristics of these different types of LBPs and is developing its own next-generation assays designed to address the specific concerns with each type of product. The assays should set new precedents for release and characterization testing expectations.
Molecular assays, for example, will provide a distinct advantage over traditional microbiological methods. Not only will the uniquely designed assays save time and increase sample throughput, but will also provide better precision, and even the ability to identify and quantify distinct strains in a consortium.
“We want to be at the forefront of this kind of technology and act in the best interests of our clients. Our clients’ success is our success and we’re very invested in that,” Cowley said.
Arranta, with fully operational facilities in Watertown, MA and Gainesville, FL, and a third planned expansion in Boxborough, MA (due to come online in early 2022), believes the key to continuous innovation is the staff who provide innovative thinking.
“One of Arranta’s core values is innovation, and we actively seek future staff members who are ready to be the front line of innovation for the industry. There’s an unlimited potential in the microbiome-space, and we’re only at the beginning. Not everyone will have the opportunity to build the future of healthcare, and they can do this at Arranta,” Jenna Heyman, VP of Human Resources, said.
“Some may say ‘We can’t do that’ – but at Arranta, we want to do what others won’t,” Cowley said.
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