As more microbiome-based therapies progress through the clinic toward approval for market launch, concerns over the lack of outsourcing capacity for process development and commercial manufacturing high yield LBPs – live biotherapeutic products – are increasing. Arranta Bio has more than a decade of experience in the development and tech transfer of LBPs under GMP conditions.
Arranta Bio was formed to meet the significant need in the microbiome space for experienced CDMOs with early-stage development expertise through commercial manufacturing of LBPs
After it’s founding, Arranta secured extensive capabilities in process development and early clinical scale-up of LBPs and more than a decade of institutionalized knowledge and experience gained developing microbiome products that achieve critical product attributes – such as high final form cell viability, long-lasting stability, and the appropriate administration release profile.
Our unique perspective, which derives from a knowledge base not only in microbiology, but also chemistry and other fields, allows us to evaluate projects with an eye to understanding and defining the process that will provide the optimal conditions to manufacturing high yield LBPs and for the survival and growth of the microbes. Attention to even seemingly insignificant microbiological details is critical to determining the most efficient processes to cultivate and harvest these unique organisms.
To be successful developing scalable LBP processes, a CDMO must have foundational expertise in process development and manufacturing of microbiome-based products. Traditional approaches to process development and manufacturing are generally not effective, given the unique characteristics and processing requirements of LBPs compared to, say, growing mammalian cells that are then lysed so that a protein can be purified.
It is essential to consider the entire process of manufacturing high yield LBPs from the start rather than limiting the focus to just the most proximal stages at a given time. As products are scaled up, many of the critical product attributes become exponentially more important — it is critical that this is understood at the earliest possible stages of development to avoid expensive and time-consuming development rework during the later stages of clinical development. At Arranta Bio, we assess what can be achieved at commercial scale, designing processes for the large-scale initially, and then scaling them down to the lab scale for intensive development.
As a result, Arranta Bio offers customers a comprehensive development and manufacturing program for aerobic, anaerobic, and spore-forming LBPs that considers all stages on the path to commercialization. Our proprietary ALIVE Biotherapeutic Products™ (aLBP) platform has several advantages, as embodied by the ALIVE acronym:
Our actALIVE™ Fast-to-Clinic Program delivers high yield LBPs and high-viability LBPs for clinical trial use in an accelerated timeline based on Arranta’s ALIVE Biotherapeutic Products™ manufacturing platform. With fit-for-purpose cGMP manufacturing capabilities for the supply of clinical trial material and commercial quantities, companies in the microbiome space now have access to the specialized expertise, world-class team and facilities needed to bring novel medicines to patients.
Learn more about our ALIVE LBPs Program and our extensive experience, or contact us using the form below to schedule a discovery call with our team.