About

OcyonBio is a game-changing company that offers an innovative solution to the challenges faced by life science organizations in manufacturing and development. We provide dedicated autonomous manufacturing capacity, along with an interconnected infrastructure and cutting-edge systems, to support every stage of the product lifecycle—from early development and pre-clinical phases to clinical trials and commercial production. Unlike traditional approaches, OcyonBio operates as a next-generation cGMP incubator space, boasting a comprehensive range of regulatory capabilities and abundant resources. Our goal is to empower our partners with the necessary tools and support to generate critical CMC data, facilitating smooth and efficient regulatory applications. With OcyonBio, companies can bid farewell to the costly and time-consuming process of building their own facilities. We offer a flexible solution that safeguards intellectual property, streamlines project schedules, optimizes resource allocation, and minimizes the risks associated with new product introduction. By eliminating the need for expensive infrastructure, we reduce overall costs, freeing up resources that can be allocated towards research, development, and innovation. Our manufacturing and development spaces are carefully designed to operate autonomously, ensuring maximum efficiency and productivity. At the same time, they remain interconnected with essential systems to meet the clinical and commercial requirements of our partners. This interconnectedness enables seamless collaboration and information flow, further enhancing the success of your projects. Partnering with OcyonBio means gaining access to a state-of-the-art facility without the burden of construction costs, while enjoying the flexibility to adapt and scale operations according to your needs. We empower you to focus on what matters most—advancing your life science initiatives—while we take care of the manufacturing and development processes. Experience the future of manufacturing and development with OcyonBio. Together, we will revolutionize the life sciences industry, unlocking new possibilities and achieving groundbreaking results. Contact us today to embark on a transformative journey towards success. About OcyonBio OcyonBio redefines innovation in life sciences manufacturing and development. Our tailored solutions address key industry challenges, offering dedicated autonomous manufacturing capabilities and a seamlessly integrated infrastructure. By covering every stage of the product lifecycle, from early development to commercial production, we streamline the path to market success. As pioneers of next-generation cGMP incubator spaces, OcyonBio provides expansive regulatory expertise and abundant resources. Our mission is to equip our partners with essential tools for generating critical CMC data, ensuring efficient regulatory submissions. Choose OcyonBio and say goodbye to the burdens of constructing your own facilities. Our flexible, secure solutions protect intellectual property, enhance project timelines, and optimize resource use, all while minimizing risk during new product introductions. Our approach not only cuts costs but also reallocates savings to foster further research, development, and innovation. Our facilities are designed for peak efficiency and productivity, maintaining connectivity with vital systems to support both clinical and commercial demands. This integration fosters unparalleled collaboration and information exchange, propelling your projects forward. By partnering with OcyonBio, you gain access to cutting-edge facilities without the overhead of construction costs, coupled with the agility to scale operations as needed. Focus on advancing your initiatives; we'll handle the complex manufacturing and development logistics. Discover the future of life science manufacturing with OcyonBio. Join us in revolutionizing the industry, unlocking new possibilities, and achieving extraordinary outcomes. Contact us today to start your transformative journey toward success. About OcyonBio OcyonBio redefines innovation in life sciences manufacturing and development. Our tailored solutions address key industry challenges, offering dedicated autonomous manufacturing capabilities and a seamlessly integrated infrastructure. By covering every stage of the product lifecycle, from early development to commercial production, we streamline the path to market success. As pioneers of next-generation cGMP incubator spaces, OcyonBio provides expansive regulatory expertise and abundant resources. Our mission is to equip our partners with essential tools for generating critical CMC data, ensuring efficient regulatory submissions. Choose OcyonBio and say goodbye to the burdens of constructing your own facilities. Our flexible, secure solutions protect intellectual property, enhance project timelines, and optimize resource use, all while minimizing risk during new product introductions. Our approach not only cuts costs but also reallocates savings to foster further research, development, and innovation. Our facilities are designed for peak efficiency and productivity, maintaining connectivity with vital systems to support both clinical and commercial demands. This integration fosters unparalleled collaboration and information exchange, propelling your projects forward. By partnering with OcyonBio, you gain access to cutting-edge facilities without the overhead of construction costs, coupled with the agility to scale operations as needed. Focus on advancing your initiatives; we'll handle the complex manufacturing and development logistics. Discover the future of life science manufacturing with OcyonBio. Join us in revolutionizing the industry, unlocking new possibilities, and achieving extraordinary outcomes. Contact us today to start your transformative journey toward success. OcyonBio – Empowering Innovation in Advanced Therapies Headquartered in Aguadilla, Puerto Rico, OcyonBio is a next-generation contract development and manufacturing organization (CDMO) specializing in the development and commercial manufacturing of biologics, cell and gene therapies (CGT), and aseptic drug products. With a foundation built on flexibility, speed, and regulatory excellence, OcyonBio provides integrated solutions for companies developing complex, life-saving therapies. Our Mission To enable biotechnology innovators to bring breakthrough therapies to market faster and more efficiently by providing world-class infrastructure, tailored contract development and manufacturing organization (CDMO) services, and a unique partnership model that empowers scientific teams. Our Services OcyonBio offers a comprehensive suite of services to support the entire development lifecycle: 1. Biologics and CGT Manufacturing • Cell Therapy: Autologous and allogeneic platforms, including CAR-T, TCR, and stem cell-based therapies. • Gene Therapy: Viral vector production (AAV, LV), plasmid DNA production, and fill-finish. • Biologics Drug Substance Manufacturing: Monoclonal antibodies and other recombinant proteins produced using mammalian expression systems (e.g., CHO). • GMP Suites: Modular, BSL-2 compliant cleanroom spaces for Phases I–III and commercial production. 2. Aseptic Fill & Finish • State-of-the-art isolator-based systems for vial and syringe filling. • Flexible batch sizes support clinical through commercial-scale products. 3. Analytical Development & Quality Control • Custom assay development for identity, purity, potency, and safety. • In-house microbiology, molecular biology, and biochemical analytics. • Stability studies, method validation, and release testing. 4. Regulatory & Quality Support • Full cGMP compliance under FDA and EMA guidelines. • Support for IND, IMPD, and BLA submissions. • Quality-by-Design (QbD) implementation and risk-based validation strategies. 5. Development & Technology Transfer • Process development and scale-up from R&D to GMP. • Tech transfer frameworks that minimize risk and timelines. • Collaborative team integration between client scientists and OcyonBio experts. Flexible Infrastructure Model OcyonBio offers a hybrid model that combines the benefits of a Contract Development and Manufacturing Organization (CDMO) with the autonomy of dedicated, client-operated space. Companies can lease customizable GMP suites, QC labs, and support areas within our purpose-built campus while accessing centralized services such as: • Centralized QA/QC and regulatory support • Supply chain and cold chain management • Utilities, warehousing, and environmental monitoring • Trained labor pool and technical assistance This unique model accelerates facility readiness while preserving control over critical manufacturing processes. Facilities OcyonBio's 200,000+ square-foot campus in Aguadilla includes: • ISO 7/ISO 8 cleanrooms • Dedicated vector production suites • Aseptic filling lines with isolator technology • Analytical and QC laboratories • Office and training space for client teams • Modular expansion zones to meet growing capacity needs Puerto Rico offers a strategic geographic and regulatory advantage: U.S. jurisdiction, cost-effective labor, strong logistics, and significant tax incentives. Why Partner with OcyonBio? • Speed to Clinic and Market: Accelerated timelines through modular buildouts and technology transfer expertise. • Customized Engagement Models: From comprehensive CDMO services to co-located manufacturing partnerships. • Deep Expertise: Decades of experience across regulatory, operations, process development, and manufacturing. • Resilient Supply Chain: On-island capabilities minimize international shipping risks and ensure control over the supply chain. • Incentivized Operating Environment: Leverage Puerto Rico’s Act 60 incentives, workforce development programs, and export advantages. Your Partner from Discovery to Commercialization Whether you’re a biotech startup advancing a first-in-human product or an established biopharma seeking a strategic CGT manufacturing partner, OcyonBio offers the agility, infrastructure, and scientific depth to bring your innovations to life. Join us at BIO 2025 to explore how OcyonBio can support your next breakthrough.