Last week, OcyonBio announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. in Puerto Rico.
According to the press release "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." Robert Salcedo, the CEO of OcyonBio, stated, "[w]ith 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." The press release notes that the plant will be located in Aguadilla, Puerto Rico and include more than 95,000 ft2 of cleanroom and biomanufacturing space, with biosimilar production slated in 2022.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.