What We Do

Fast, Full-Service CDMO

iBio is a full-service biologics CDMO equipped to take you from pre-clinical development through regulatory approval, to commercial product launch.

FastPharming® Advantages

Because the cell line development phase is eliminated, FastPharming offers significant time savings compared to traditional expression platforms. For instance, iBio produces milligram quantities of protein in as little as 6 weeks, gram quantities in 3 months, and greater than 10g of cGMP material in only 8 months.

Additionally, FastPharming processes are easily scalable, produce high quality product, are cost efficient, deliver improved safety, and facilitate superior glycosylation control.

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Technology Applications

The FastPharming platform produces a variety of recombinant products including:

  • Biobetter and biosimilar antibodies
  • Antigens for subunit vaccine design
  • Virus-like particles (VLP)
  • Lysosomal enzymes
  • Blood factors and cytokines
  • Scaffolds, maturogens and materials for 3D Bioprinting and biofabrication

Commitment to Quality

The Quality Department at iBio is staffed with highly motivated and skilled professionals who are knowledgeable in biologics manufacturing and development:

  • Quality Management Systems (QMS)
  • Product control systems, inclusive of quality control and environmental monitoring
  • Quality assurance batch review and release
  • Vendor qualification
  • Regulatory affairs/Regulation intelligence

iBio’s QMS and cGMP systems are designed to comply with the standards of the FDA and external US regulatory agencies. 

iBio’s Quality Policy

iBio is dedicated to maintaining the effectiveness of the quality system, complying with applicable regulatory requirements and exceeding customer expectations by delivering quality products through process management and continual improvement.

Learn how iBio is working with its partner, EdgePoint AI, to enhance the data integrity and security of iBio's manufacturing operations.

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