New partnership delivers clinically proven products and manufacturing processes for advanced therapies
SEATTLE, Aug. 16, 2022 — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services.
The partnership creates an end-to-end solution for the development and production of hMSC and exosome therapeutics leveraging RoosterBio’s well-established cell and media products and process development services, coupled with AGC Biologics’ global cell and gene therapy manufacturing capabilities.
RoosterBio will utilize its extensive portfolio of cell and media products to develop robust, scalable processes for hMSC and exosome therapies. These capabilities include genetic engineering of cells and exosomes to express therapeutic targets, upstream processing in both 2D flask and 3D bioreactor systems, downstream purification to achieve desired purity and potency, and comprehensive analytical characterization of the resulting formulated cell or exosome therapy.
AGC Biologics will utilize its global network to provide full Process Development, cGMP Manufacturing, Quality Control and Regulatory services for pre-clinical and phase I/II clinical trials, with the ability to scale to Phase III and commercial production. The CDMO also offers a range of development and manufacturing scales that can be tailored to the specific needs of drug developers in different regions worldwide. The AGC Biologics scientific teams have over two decades of experience in advanced therapy production and manufacturing, and have brought three commercial products to market. The global CDMO’s network of sites offers the latest cell therapy technologies and processes, including allogenic and autologous systems and techniques.
“AGC Biologics is happy to be partnering with RoosterBio. They have a reliable method for producing engineered cells and exosomes that can help developers create life-saving therapies,” said Patricio Massera, Chief Executive Officer of AGC Biologics. “When you combine their work and expertise with AGC Biologics’ scientific knowledge and global manufacturing services, it creates a comprehensive offering that can help these developers save time and money, and get their treatments in the hands of patients in need.”
“AGC Biologics has an outstanding track record of success in the manufacture of clinical and commercial advanced therapies and an ever-expanding global network to meet the needs of our customers,” said Tim Kelly, Chief Executive Officer of RoosterBio. “Biopharmaceutical companies striving to develop engineered cell and exosome therapies require proven, flexible technologies paired with reliable and scalable manufacturing solutions. This collaboration was conceived to deliver that end-to-end solution for our customers and I am thrilled to partner with AGC Biologics to translate our hMSC and exosome technologies into advanced therapy products that have the potential to bring curative treatments to patients in need.”
More details on this partnership and the joint offering from RoosterBio and AGC Biologics will be released in the coming months.
AGC Biologics’ global cell therapy services and viral vector capabilities utilize proprietary platforms developed to address the evolving advanced therapies market. To learn more about the company and its complete list of CDMO services visit www.agcbio.com.
RoosterBio accelerates human mesenchymal stem/stromal cell (hMSC) and extracellular vesicle (EV) product and process development to fuel the rapid commercialization of scalable regenerative cures. Our high-quality hMSCs, bioprocess media, genetic engineering tools, and EV production solutions are paired with expert bioprocessing knowledge to progress therapeutic developers from concept to first-in-human testing and commercial manufacturing at reduced cost and increased productivity. With optimized, scalable processes, Type 2 Drug Master Files, and cGMP products, we have enabled therapeutic programs to traverse their path to clinical translation in under 1 year. RoosterBio is driven by client’s success and creating a world where safe and effective regenerative medicines are rapidly developed and widely available on a global scale.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. To learn more, visit www.agcbio.com.