Supporting STEM Students with MassBioEd Career Ambassador Event

As part of its on-going Corporate Social Responsibilities efforts, Arranta Bio recently participated in a MassBioEd Career Ambassador event with Pioneer Valley Regional School, in Northfield, Massachusetts. Career Ambassadors met with the same class over three sessions in December 2020 to bring real-world examples of microbiology and pharmacy as a career and highlighting the importance of microbes to human health. 

Melanie Cerullo, SVP Quality and Regulatory at Arranta Bio, and another biotech professional worked with Nikki Pullen’s AP Environmental Sciences class.  Melanie provided an overview of her career, the science of the human microbiome and its incredible diversity, and the work that Arranta Bio does to help its customers develop and manufacture new live biotherapeutic products to treat diseases. The discussion also included the process of how to grow and evaluate microorganisms. 

Through the generosity of Third Room, Ms. Pullen’s class also received a grant to purchase supplies for the students to get a hands-on experience studying microbes in their own environment. With this grant, Ms. Pullen purchased agar plates and other supplies for students to complete their projects evaluating different bacterial populations, including soil and skin microbes.  The pictures below show the work product of Pioneer Valley students’ efforts to plate microorganisms and the resulting diversity inherent in the microbiome. 

These students are the future of the life sciences industry. Diversity makes us stronger and nowhere is that more apparent than in the Marvelous Microbiome™!

Experience is Key for Manufacturing High Yield LBPs

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.

Arranta Bio Named Honoree in GrowFL Companies to Watch

Arranta Bio is pleased to be among the top 50 second-stage companies in Florida selected as honorees in the 2020 GrowFL Florida Companies to Watch, a statewide competition that identifies companies expected to see significant growth over the next several years. The 2020 GrowFL Florida Companies to Watch awards celebration is brought to you by Nperspective CFO & Strategic Services, in association with the Edward Lowe Foundation.

Arranta Bio, a world-class CDMO supporting pioneers in the microbiome-based clinical space, was one of 82 finalists announced in September; Fifty  honorees were selected after a final round of judging by a panel of independent judges comprised of past honorees, economic development leaders and corporate partners of GrowFL.  Companies were judged on a number of criteria including: growth in number of employees; impact of the business in the job market; increase in sales and/or unit volume; current and past financial reports; innovativeness of the product or service; response to adversity; and contributions to aid community-oriented projects.  

Companies to Watch was developed by the Edward Lowe Foundation as a unique way to recognize and honor second-stage companies that demonstrate high performance in the marketplace with innovative strategies and processes, making them “worth watching.” GrowFL received more than 400 nominations for the award this year.

“These stand-out companies are all led by entrepreneurs, and have demonstrated not only their willingness to grow, but their capacity to do it successfully,” said Dr. Tom O’Neal, GrowFL Founder, said. 

“We’re delighted to receive recognition for an amazing year of growth, building on a decade of commitment to this space, and looking forward to helping the microbiome research and biotechnology community in Gainesville, Fl thrive,” Aaron Cowley, chief scientific officer at Arranta Bio, said.

“The 50 second-stage companies named as GrowFL Florida Companies to Watch Honorees reflect the exceptional leaders who are making a difference in growing and diversifying the state of Florida,” said Jennifer Barrows, Chairman of the GrowFL Advisory Board and Business Development Executive with Withum. “Second-stage companies are defined as those with 6 to 150 full-time employees and between $750,000 and $100 million in annual revenue. As the only organization in Florida that focuses exclusively on this state of business, GrowFL works to develop program specifically to support and celebrate them.”

In the 12 months since acquiring Captozyme, the FL-based CDMO founded in 2009 by Dr. Aaron B. Cowley, Arranta Bio has invested more than $16 million into the Gainesville facility, including an expansion of the process development labs, which added capacity for up to 45 process development scientists, and expansion of the GMP clinical manufacturing area. Arranta’s Florida location has added more than 40 new employees in the last year, more than tripling the headcount.

From 2016 through 2019, these companies generated $813 million in revenue and added 668 employees, reflecting a 103% increase in revenue and 113% increase in jobs for the four-year period. That translates into a 27% average annual revenue growth and 20% average annual growth in employees.

Even through the pandemic, these companies projected continued growth in 2020, with a 15% revenue increase and 17% growth in employees compared to 2019. If their projections hold, these companies will have generated $1.14 billion in revenue and added 887 employees over the last five years — a 133% increase in revenue and 150% increase in jobs since 2016. Companies named to the list will be officially recognized at the 10th Annual GrowFL Florida Companies to Watch Celebration on February 18, 2021 at the Hammock Beach Resort and Spa in Palm Coast, FL.  The event will also be broadcast live.

Aaron Cowley Talks Process Development of LBPs

As an inorganic chemistry student at Benedictine College, Aaron Cowley, Arranta Bio’s Chief Scientific Officer, didn’t expect to someday lead a biotechnology company focused on the process development of LBPs. Even as a doctoral and post-doctoral student, Aaron’s passion was the potential therapeutic nature of enzymes, which led him to start Captozyme, a CDMO supporting the development of enzyme-based therapies to treat a variety of conditions, specifically kidney disease.

After founding Captozyme in 2009, Aaron and his multi-disciplinary team of researchers and lab technicians, discovered a gap in process development of LBPs while working with a company that had invested millions of dollars into clinical testing, only to have the project fail upon tech transfer. The Captozyme team learned that not all organisms — especially challenging species of LBPs – can be kept viable in the same ways; what makes one organism ‘happy’ can cause another to fail.

“What allowed Captozyme to find the source of the problem – and to develop the expertise in LBP processes — is our unique perspective. Our knowledge base in microbiology is complemented by team members with backgrounds in chemistry and other fields. As a result, we bring a different element to the table and can evaluate projects with a different set of eyes,” Aaron says.

Aaron believes a perspective from a variety of fields, from chemistry to engineering, is the key to the successful process development of LBPs. The team spent 10 years researching, testing and amending the processes for 125 different isolates, establishing a decision tree as they worked to help determine the nature of each species and the various isolates associated with it — a project that has boosted the team’s ability to make the right choices at the start of each project.

In November 2019, Captozyme’s service division became part of Arranta Bio after recognizing a further need to support microbiome-based candidates in early-phase, preclinical and clinical development by using the same decision-making processes Aaron and his team spent 10 years perfecting.

Arranta Bio’s goal when designing process development of LBPs is to help clients scale practically, efficiently and cost-effectively— a process that starts where it will end. The Arranta Bio team first determines the best process for successful large-scale and commercial implementation, which will be produced in Arranta Bio’s new facility in Watertown, MA, then scales back down to the cGMP facility in Gainesville FL for intensive development.

By serving an under-accommodated industry of start-up innovators with process development of LBPs, the company is poised to help bring microbiome-based therapies to market resourcefully, thanks to passion, persistence and a whole lot of perspective.

Read Aaron’s interview, including future plans for Arranta Bio’s Gainesville FL and Watertown MA facilities and the influence of microbiome-based therapy industry, the Quarter 1 edition of Pharma Almanac.