our Proprietary Technology
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.
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.
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.