IBIO SERVICES PORTFOLIO
iBio and its regulatory partner CBR International offer a full-suite of regulatory services. Early stage risk assessment, strategic regulatory pathway planning, pre-IND support, complete CMC data production, and IND writing and filing can assist the customer to shorten the “time to clinic”.
CBR also offers “True Submit”, a complete e-filing system that is compliant with FDA electronic submissions requirements.
Finish and Fill Services
iBio offers formulation and fill services to customers, whether the product was manufactured at iBio or not. Our modular, autonomous clean-rooms provide a discrete formulation and automated fill service. Typical fills range from very small “hand fills” to thousands of vials per day in our automated filler/labeler system. iBio can offer cGMP stability testing and cGMP storage to compliment our vial filling capability.
iBio uses the Nicotiana benthamana plant as the primary bioreactor. The plants are transfected with a transient vector system that produces the protein of choice in 5-7 days. The system is a proven producer of monoclonal antibodies, vaccines and other therapeutic proteins.
Our pilot facility can produce milligrams of material for customer evaluation in weeks. Our large-scale production facility can produce hundreds of kilos of a biologic per year. Scale-up is a matter of growing more individual plants. Our facility can grow 2.2 million plants of “in process inventory” continuously and grow over 340,000 kgs of plants per year. The bioreactor never changes; therefore, the product is stable and identical at all levels of production
Lab to Launch means our customers can start with us and stay with us.
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PROTEIN PRODUCT CHARACTERIZATION AND PROCESS DEVELOPMENT
iBio employs sophisticated genetic engineering tools to optimize the expression and function of therapeutic protein candidates.
The well-equipped process development laboratory and experienced scientists are dedicated to “quality by design”. iBio can develop a scalable-process rapidly using design of experiments (DOE) platforms and multi-variable analysis systems which contribute to understanding a process “design space”.
The team has a palette of tools for molecular engineering including codon optimization yield improvement and glyo-engineering.
UNDER “ONE ROOF”
iBio can go from “Lab to Launch”. The process development group transfers technology to manufacturing in the same building, to rapidly enable small (gms), intermediate (kilogram), and large-scale (100’s of Kgs) cGMP manufacturing of therapeutic proteins.
Proper segregation of products and process makes iBio truly a “multi-product” facility.
Release and in process quality assays
The iBio QC lab can support most release assays with a wide range of instruments and techniques. iBio also has a complete BSL-2+ laboratory for cell-based assays eg. ADCC, and antibody binding.
Advance Mass Spectrometric Analyses
iBio’s lab is also equipped with an LC-MS-MS, triple-TOF mass spectrometer and can provide sophisticated analyses of protein structure and post-translational modification, including detailed qualitative and quantitative glycan analysis. This service is available to any outside customer, whether the protein was manufactured at iBio or not.
iBio will empower its customers to use the plant-based manufacturing system if they so desire. The design/build team will work with the customer to design a custom facility for the manufacture of a specific product or products. This service is available globally and projects are currently underway. The iBio design team partners with Beck Technologies, Beck Architecture, and Rockwell Automation to bring the latest in computer aided modeling and design services to the project.