OcyonBio, LLC is creating cell and gene therapy partnership development and manufacturing organization (PDMO). OcyonBio will provide preclinical through commercial manufacturing, including process development, viral vectors, cell banking, cell processing, and supporting testing capabilities.
The 100,000+ square-foot facility also has full cGMP clean rooms to support incubator space for pre-clinical and clinical phased companies. Facilities are located in Puerto Rico, a U.S. pharmaceutical center of excellence and financial advantages that can reduce the cost of research and development by more than 50%.
Robert Salcedo has 25+ years of experience in Biotechnology and Solid Dose Manufacturing experience, which includes 7+ years of working closely with start-ups in gene and cell therapy companies. He led executive teams in Developing Regulatory, CMC, Clinical, and manufacturing scale-up strategies and constructing commercial facilities ranging from $20MM to $1.5Bn. He was a leader in Amgen’s construction and technology transfer in Puerto Rico, which supplies drug products to the world. He previously consulted and advised 50+ clients focused on both gene and cell therapy and biologics companies.
“I am thrilled to lead OcyonBio. We are developing a Partnership Development Organization model, which, combined with the tax incentives offered by Puerto Rico, makes our approach truly best in class. I am laser-focused on building a company that will solve the biggest challenge in cell and gene therapy development, which is high-quality manufacturing,” said Robert Salcedo. “Beyond manufacturing, our goals include the creation of high-performing teams and fostering an exciting and inspiring culture with a close connection to the patients and customers we ultimately serve,” he added.
Puerto Rico has long been a major center for pharmaceutical and medical device manufacturing. According to the FDA, 8% of pharmaceutical expenditures by Americans are for products manufactured in Puerto Rico. There is a well-developed ecosystem of highly skilled employees who have the technical skills needed to work in a highly regulated and safety-oriented operating environment. Puerto Rico is also entirely within the customs territory of the United States, and manufacturing is subject to FDA and other federal agency oversight.