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.
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.