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The facility has a current capacity of approximately 3500 kg of biomass per week and can be expanded to over 7000 kg of biomass per week by building out an additional existing grow room. The iBio facility in Bryan-College Station, TX can deliver grams to hundreds of kilograms of product depending on customer requirements.

Advantages provided by iBio

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Economical at Every Stage. iBio is cost effective for early stage companies. Our detailed This email address is being protected from spambots. You need JavaScript enabled to view it. has shown the cost and time advantages of using the iBio technology versus or alongside CHO based systems.
Rapid production of candidate molecules for lead selection. A typical customer can have milligrams of protein for evaluation within 5-6 weeks after contract initiation
Protein Function and Composition Improvement Sophisticated tools of synthetic biology provide for the modification of DNA, protein sequences and protein structure to create patentable product candidates with improved function, stability, potency, and other desirable characteristics.
Protein yield and stability optimization. Practical production issues, such as initial expression yield of the desired protein and the stability of the protein during downstream processing can often stall the drug development timeline. iBio offers process development services that include proprietary approaches to improved gene expression through codon optimization and significant know-how to eliminate protease activity and improve unit process yields.
Production process development, optimization, and scale-up. The iBio pilot facility is designed to be cGMP compliant and uses the same plants, grown under the same conditions in the large-scale facility, as feed stock. This assures that the product produced and characterized will be the product that will be produced at any scale needed along the clinical path, resulting in time and expense savings. In mammalian cell production of proteins, product consistency remains an issue across different volumes of production. Plant-based expression produces homogeneous and stable glycosylation patterns at every scale, because the plant is the bioreactor and remains the bioreactor through all stages of scale-up. No harmful immune responses have been attributed to plant-specific glycan structures.
iBio quality by design approach. iBio provides a complete process development and product characterization capability, equipped to evaluate multiple purification systems simultaneously. A “quality by design” platform drives numerically defined experiments to move the process rapidly to a “design space” that offers high reproducibility of product quality.
Unparalled time savings: A savings of six months to reach an IND can be achieved using the iBio plant-based system in comparison to CHO based systems.
Manufacturing of bulk drug substance for commercial use.  iBio is a large capacity CDMO and  offers clients the opportunity to transition to large-scale production in a virtually seamless manner. Most CHO CMO’s have only a few larger 1000 and 2000 liter reactors. If more protein is required, most CDMOs require customers to move to a larger CMO. Technology transfer and QA transfer requires months and considerable expense. At iBio, we simply grow more plants.
Global Regulatory. Early stage companies need guidance to understand what the FDA and EMA require to move a product forward. iBio and its preferred regulatory services partner, CBR International, Boulder, Colorado, can provide support through the entire clinical and drug development cycle including including e-publishing of FDA filings.

The Capabilities of iBio

Transitioning to large-scale production is very low risk with iBio. Large growing rooms are operational at any time since they also supply plants to the pilot facility. The large infiltrator used for transfecting plants for the pilot facility is in a constant state of readiness and fully commissioned. The client faces no engineering risks in the transition from clinical lot production to full commercial lot manufacturing. Mid-stream facilities such as the large homogenizers, disk-stack centrifuge and filtration systems are also commissioned and ready for scale-up cGMP activities. The facility has a current capacity of approximately 3500 kg of biomass per week and can be expanded to over 7000 kg of biomass per week by building out an additional existing grow room. All of the downstream equipment was sized to handle the expanded production.

Downstream purification is accomplished in a series of autonomous, modular cleanrooms, designed and built by G-CON. The autonomous clean rooms or PODs house the separate unit process for downstream processing including protein purification, finish and fill. The major process areas are as follows:

  1. Biomass Production Growing Hydroponic Plants - Capacity to grow over 300,000 kg/year and vacuum infiltrate transient vectors.
  2. Extraction and Separations - Automated systems for harvest and clarification, filtration, TFF and chromatographic purification.
  3. Formulation and Sterile fill/finish - Separate classified spaces for buffer exchange, formulation and sterile fill and finish.
  4. Advanced Analytical Capabilities - Development of bio-assays in our BSL-2+ facility with full product release.
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Small-scale finish and fill

iBio offers small scale, sterile vial filling services. Our filling suite is equipped for both automated sterile vial fill and manual vial fill. iBio economically provide fills of hundreds to thousands of vials for early stage clinical trials and stability testing. The filler suite is equipped with an M & O Perry vial filler and a Newman Labeler and has a biosafety cabinet for manual sterile fills.

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Mass spectrometry and other analytical services

Mass Spectrometry Protein Characterization and other analytical services iBio offers specialized services that can be accessed on an “ad hoc” basis. iBio has a very well equipped analytical core that specializes in protein characterization using mass spectrometry. 

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Stability testing and cell based assays

Stability testing is also available in iBio’s lab facilities. Cell based assays can be developed or transferred to our BSL-2 laboratory dedicated to this purpose. iBio offers other standard assays as part of product release testing.

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Engineering design build services

iBio can offer early stage conceptual design and process modeling using tools like DESTINI Profiler. This is accomplished by a close collaboration with long-time partners in process and mechanical engineering and design-build construction.

Applications

iBio’s technology platform allows for novel proteins to be produced rapidly at scale. The technology and facility capabilities are applicable to the development of monoclonal antibodies, biotherapeutics, ADCs, vaccines, and combination medical devices. 

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“Our first product selection is very important but is only the beginning of what I believe CC-Pharming and iBio can do together with our combined scientific approach to the business of biopharmaceuticals. I have evaluated many technologies over many years, but I’ve never been as enthusiastic about any process as I am about the approach we are undertaking with iBio.”

Dr. Kevin Wang, Chairman and CSO, CC-Pharming

Areas of Expertise

Antibody Drug Conjugates

Diagnostics

Monoclonal Antibodies

Parasitic Pathogen Vaccines

Viral Disease Vaccines

Enzyme Replacements

Oncology

Bacterial Disease Vaccines

Therapeutic Vaccines

Plasma-Derived Proteins

Market

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