Production of a range of recombinant products including monoclonal antibodies, antigens for subunit vaccine design, lysosomal enzymes, and many moreExplore FastPharming
Full range of development and manufacturing services required to move projects from pre-clinical, market launch, to ongoing commercial requirements phasesLearn More About iBio's Services
Plant-based expression shortens development timelines and provides for seamless scale-up. Glycan engineering in plants affords greater control and can deliver increased product potency and quality.Explore FastPharming
iBio offers development and manufacturing services for biologic drug substances and drug products, built around our proprietary plant-based platform technology. Client support is offered from early development through fill and finish for research-grade, pre-clinical, clinical and commercial material, including extensive scale-up and analytical and regulatory assistance. Customers have the option of adopting iBio’s technology in their own facilities, which iBio will help design to ensure optimal production under cGMP-compliant conditions.
NEW YORK, June 19, 2019 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSE AMERICAN:IBIO) (“iBio” or the “Company”) today announced the activation of its new cGMP sterile fill-finish services operation via the signing of a supply agreement with a clinical-stage biopharmaceutical company developing breakthrough gene and cell therapies (the “Customer”).
FastPharming overcomes the limitations of other expression systems:
FastPharming optimizes gene-expression, glycosylation, and purification parameters to deliver a robust process for your APIs.
The FastPharming system transfects at large-scale to easily and reliably deliver biologics in clinical trial or commercial quantities.
In-line labelling allows serialization of vials and bottles for greater quality assurance of mAbs, viral vectors, and other biologics.
Experienced analytical staff provides method development and validation support with expertise in protein characterization using mass spectrometry.
Quality systems have been carefully constructed to meet cGMP requirements and iBio can provide regulatory guidance given the team’s experience with therapeutic development.
When the time is right, iBio facilitates insourcing by designing and building your own environmentally sustainable FastPharming facilities.
The FastPharming platform produces a variety of recombinant products including:
iBio offers the CDMO capabilities needed to develop and deliver biologics to market - process development, scale-up, cGMP manufacturing, bioanalytical product characterization, aseptic fill/finish, and quality and regulatory support.