OcyonBio announces manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing including process development, plasmid DNA, viral vectors, cell banking, cell processing, and supporting testing capabilities.
“With our partnership development manufacturing organization model, OcyonBio is the perfect partner to usher in these biosimilars to the U.S. Biosimilar Solutions, Inc. will have streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits,” said Robert Salcedo, CEO of OcyonBio.
The plant, which will include more than 95,000 ft2 of cleanroom and biomanufacturing space, will be located in Aguadilla, Puerto Rico, with biosimilar production slated in 2022. Biosimilar Solutions previously entered a license and development with Reliance Life Sciences, who markets biosimilars in India and overseas markets. Biosimilar Solutions expects to manufacture in-house commercial-scale facilities for recombinant proteins and monoclonal antibodies (mammalian, microbial cell culture, fill-finish for vials and syringes).
Daniel Chang, co-founder of BioSimilar Solutions, said, “We are excited to start working with OcyonBio in Puerto Rico. There is no doubt the island’s capabilities in the bioscience sector will help us meet our goal of making medicines affordable for all.”
The company will leverage access to skilled talent, government incentives and other assets to establish world-class facilities dedicated to the research, development and manufacture of biosimilar therapies, including a Covid-19 vaccine, new cells and gene therapy, biological products, support clinical studies, among others. Through its operations, Biosimilar Solutions strengthens Puerto Rico’s role as a global center for pharmaceutical innovation, manufacturing and distribution.
About OcyonBio, LLC
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. A cGMP incubator look-a-like space with regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems to support clinical and commercial requirements. OcyonBio provides companies its own space, providing flexibility to protect IP, manage schedules, resources, and new product introduction, reducing cost and risks.
About Biosimilar Solutions, Inc.
Biosimilar Solutions is a leading company that develops and commercializes high-quality therapeutics for major regulated markets, focused on affordability, increasing patient access with Uncompromising Quality. Our team includes industry veterans with decades of experience in pioneering biologics companies, such as Amgen and Genentech, where they were responsible for leading, establishing, these organizations’ core capabilities in process development, protein manufacturing, analytical research and development. Team members have contributed to filing 100+ Investigational New Drug applications, or INDs, and 40+ marketing applications, including those for Enbrel, the originator product for our lead biosimilar product candidate. We also assembled a distinguished Scientific Advisory Board of leading scientists.