OCYONBIO cGMP space and Viral Manufacturing Capabilities Ready to Go !
Happy New Year to our OCYONBIO team, THANK YOU for the extra ordinary 2021.
In 2022, our goal is enabling our partnership development organization campus in Puerto Rico. Our plans include bringing online cGMP Cell processing, viral manufacturing, fill finish and Gene and Cell Therapy space and capabilities in the first half of 2022.
OcyonBio is a partnership development and manufacturing company. Our team supports companies from startups to Series A, B & C funding companies.
OCYONBIO campus is an environment where companies who have new scientific ideas from early research to commercialization can call our campus home.
Our campus has Interconnected Autonomous manufacturing capacity with interconnected systems and infrastructure to support your R & D, pre-clinical, early devolvement, Clinical and commercial needs.
The Interconnected autonomous manufacturing model allows your organization to use our expertise to manufacture your products or lease space where you control your resources, process, and schedule. Additionally, OCYONBIO has ISO 8/7 ready space that can be customized for your process. Ocyonbio allows your team to focus on the science while we work on Facilities, Equipment, Materials, Resources, Documents, Test and Quality Systems.
Ocyonbio has capabilities Viral vector manufacturing (AAV, LENTI, RETRO), Gene therapy, Biologics, Fill Finish ready for cGMP operations in Q1-2022
Our expertise and campus provide CMC in the box. Our systems and processes support your phased appropriate global regulatory requirements with expertise to manage both manufacturing and regulatory needs.
Ocyonbio has developed space to support early process development and R & D, pre-clinical, clinical and commercial manufacturing with shared freezer & incubator farm, warehouse, administration, Quality systems, quality control laboratory supporting all phases of CMC development
Ocyonbio campus brings an integrated approach to Biologics, Gene Therapy, Viral Vectors and Cell processing. Ocyonbio goal is to remove the hurdles that conflict with Speed and Cost.
With OcyonBio, you don’t need to build an expensive space, our affordable and available space has been designed to support pre-clinical, clinical, and commercial operations. Our process helps protect your IP by allowing your company to manage your resources, schedules, and new products while minimizing overall risks and costs. Our pre-built rooms and suites ready to support immediate process transfers.
Our disruptive model, coupled with our location in Puerto Rico USA provides significant benefits for companies in all phases of development. Starting with our team members that average 15 years of experience in Biologics, Gene and Cell Therapy, Viral, and regulatory compliance.
Our partnership development organization model provides multiple advantages to support your development journey. Our innovative approach provides critical opportunities to:
- REDUCE COST – our location, grants, credits and decree can get you up to 50% of all your spend as annual cash rebate
- INCREASE SPEED – We have ready 150,000 sqft of combined customizable ISO 8/ISO 7 space that can be customize quickly to support clinical and commercial manufacturing. Our cGMP spaces can be customized to meet your unique needs, 90 days from Zero to Start.
- BUILD CMC – We have team of experts in CMC and Regulatory that can generate all packages required for US and EU submissions.
- MAXIMIZE EFFICIENCY – Our infrastructure allows for cGMP in the box so your team can focus on science, while we focus on phased appropriate regulatory compliance
- TAKE CONTROL – Our spaces can be leased providing you with full control of your space, equipment, schedule, and resources. Development space to support your pipeline
- RELOCATE TO PUERTO RICO – In Puerto Rico USA, we speak three languages, English, Spanish and cGMP (Puerto Rico produces top 10 biologics in the world)
- TAKE ADVANTAGE OF WORLD CLASS CAMPUS – Our world class campus houses multiple capabilities where your team can leverage our ecosystem from Cell Processing to final therapeutic
- LEVERAGE OUR PEOPLE – Our team has expertise in cGMP, Regulatory compliance, CMC and phased appropriate facility design and operations
- UTILIZE OUR QALITY SYSTEMS – Our electronic paperless systems include QMS, LIMS, MES, SAP to support data collection, reporting and secured cloud-based access for 100% data availability from any place in the world.
- BENEFIT FROM OUR ECOSYSTEM – Our facility has capability to produce and test blood derived cells, viral vectors for AAV, Lenti, and retrovirus, Gene and Cell therapy, biologics, fill finish, Quality Control Lab and final packaging to comply with full commercialization requirements. Reducing need for external partners.
OCYONBIO partnership development organization model has flexible options where we can accommodate your need for space, equipment, resources, and services required to get you into clinic.
Our campus has open viral manufacturing slots in Q1-2022 to produce full cGMP virus in Retro, Lenti and AAV starting with clone development, MCB to clinical ready virus . We have over 80,000 sqft of ISO 7/8 space available for immediate occupancy or customization to support your processes.