Arranta Bio, a leading microbiome contract development and manufacturing organization (CDMO), has announced completion of its process development laboratory expansion project and a commitment to add additional early-clinical GMP capacity at its Center of Excellence for Microbiome Process Development and Early Clinical Supply.
Arranta has completed the expansion of purpose-built microbiome process development laboratories in a new dedicated building, which creates capacity for up to 45 process development scientists at its Gainesville, Florida site. Dr. Aaron Cowley, Chief Scientific Officer at Arranta and the founder of Arranta’s legacy company said, “These laboratories will allow Arranta Bio to apply our 11 years of deep experience in developing processes for microbiome products to meet the needs of an increasing number of client programs. Our proprietary actALIVE™ program provides the fastest path to the clinic, from project start to IND submission in nine months, thus allowing clients to initiate proof of concept clinical trials on an accelerated timeline.”
As part of this commitment to expand process development and early clinical GMP capacity in the USA, Arranta Bio has completed designs for and is now executing the next phase of expansion of the facility, which will include three GMP drug substance suites and a GMP drug product suite with flexible capacity to meet a range of clinical supply needs. This capacity will be installed and operational by the end of 2020.
Mark Bamforth, President and CEO at Arranta Bio, said, “As an essential business, we are pleased that we have been able to safely continue our work to support clients while expanding to meet longer-term needs during this challenging period. We previously announced a $100M investment in building capacity to support microbiome pioneers. In addition to our expansion in Florida, we have maintained progress on our late stage clinical/commercial facility build-out in Watertown, Massachusetts, which is on schedule to be completed in Q4 of 2020. We are grateful to all of our employees and contractors who have safely kept our plans on track as we build the best-in-class microbiome CDMO.”
Almost 200 companies are actively exploring the linkage between diseases and the microbiome – millions of bacteria, fungi, protozoa and viruses that live inside and on the human body – in order to identify therapeutic targets. Scientists have called it the second genome and, in fact, the number of genes in the microbes making up one person’s microbiome is estimated to be at least 200 times the number in the human genome.
Over the past decade, the industry has experienced a rapid acceleration in scientific understanding of the composition and functions of the gut microbiota. Arranta is proud to be the leading CDMO focused on supporting the supply needs of these innovator companies.
actALIVE™ is a registered trademark of Arranta Bio.