our Proprietary Technology

Key technologies developed by Dr. Niazi to reduce the COGS and improved consistency of PTMs are now widely used for commercial manufacturing of biosimilars in the USA.

Science meets technology

The inventions of Dr. Niazi are designed exclusively for improving the cost or production, but more important the quality of product--as judged by the consistency of expression. Karyo uses these technologies and transfers their use rights to licensees royalty-free.

batch size scaling

One of the costliest element of biosimilar development involves producing at-scale GMP lots for all testing; this means high development cost. The Niazi inventions of pooling bioreactors obviates this need and pooling, allowed by FDA, creates an infinitely scalable batch. 

 
 World's first continuous bioreactor that allow for cell-line age optimization. No competitors.

World's first continuous bioreactor that allow for cell-line age optimization. No competitors.

Novel testing

The key to biosimilarity is in analytical similarity demonstration; Niazi has developed novel methods such as thermodynamic stress testing to provide a proof of third and fourth dimensional structural similarity. Details are available here.

environmental control

Patents on HVAC systems, virus clearance, bioreactor exhaust controls, non-invasive monitoring, and dozens of other inventions  used by Karyo to design a process that is protectable from IP infringement, and reduces cost. Details here.