Ocyonbio LLC
Provider of partnership-based cGMP manufacturing and development spaces (PDMO model) located in Puerto Rico. Offers dedicated, customizable ISO7 cleanrooms and interconnected infrastructure to support process and analytical development, technology transfer, quality control, viral/vector and cell processing, and clinical-to-commercial scale-up. Provides facility services, supply-chain logistics for cell products, and assistance leveraging local tax incentives.
Industries
N/A
Services
cGMP manufacturing services (PDMO)
Dedicated autonomous manufacturing capacity supporting phased development from early-stage through clinical and commercial production within customizable cleanrooms.
Process and analytical development (PD/AD)
Optimization of processes and analytical methods to generate CMC data for comparability, scale-up and regulatory submissions; study protocol and report generation.
Technology transfer and manufacturing support
Comprehensive technology transfer planning, SOP and batch record development, operator training, and real-time campaign monitoring to enable partner processes in cGMP production.
Quality control and release testing
In-house QC laboratory services including compendial chemistry, microbiology, ELISA, potency assays, rapid sterility testing, stability studies and management of reference standards.
Viral vector and cell-processing services
Closed-system production of viral vectors (AAV, lentiviral, retroviral) and support for leukapheresis, cell separation and cell banking workflows.
Sterile filling, packaging and inspection
cGMP sterile filling, final packaging and inspection services to support drug product finishing and release.
cGMP manufacturing services (PDMO)
Dedicated autonomous manufacturing capacity supporting phased development from early-stage through clinical and commercial production within customizable cleanrooms.
Process and analytical development (PD/AD)
Optimization of processes and analytical methods to generate CMC data for comparability, scale-up and regulatory submissions; study protocol and report generation.
Technology transfer and manufacturing support
Comprehensive technology transfer planning, SOP and batch record development, operator training, and real-time campaign monitoring to enable partner processes in cGMP production.
Quality control and release testing
In-house QC laboratory services including compendial chemistry, microbiology, ELISA, potency assays, rapid sterility testing, stability studies and management of reference standards.
Viral vector and cell-processing services
Closed-system production of viral vectors (AAV, lentiviral, retroviral) and support for leukapheresis, cell separation and cell banking workflows.
Sterile filling, packaging and inspection
cGMP sterile filling, final packaging and inspection services to support drug product finishing and release.
Expertise Areas
- cGMP manufacturing for cell and gene therapies
- Process and analytical development (CMC)
- Technology transfer and MS&T
- Quality control and release testing
Key Technologies
- Closed-system viral vector production
- AAV / lentiviral / retroviral vector workflows
- Leukapheresis and cell separation
- ISO7 cleanroom / GMP cleanroom operations