Development of Trypsin Resistant Pan Reactive Trypsin Antibodies

Introduction

Enzyme trypsin is widely used in various biological processes such as Insulin manufacturing to cleave peptide linkers from the pro-drug C peptide removal from Proinsulin and activation of vaccine viruses. Residual trypsin analysis is used during downstream processing.

 

Stage of Development

 

Commercialization. In the past 14 months, they have been successful in immunization of trypsin to elicit immune response in Rabbits and Mice to various epitopes spanning the trypsin enzymes, optimized purification strategies to isolate trypsin resistant anti-trypsin pAb and mAb and developed immunoassay reagents and demonstrated the assay utility for monitoring trypsin clearance during bioprocessing of Biologics Eg: Insulin manufacturing.

 

Unique Features of The Product/Technology

 

The kits are customized for end users to meet global regulatory requirements. Niche product developed for Insulin manufacturers.

 

Market Potential

 

Potential therapeutic anti-trypsin engineered antibody drug for treating Pancreatitis is an unmet medical need.

 

National/Societal Relevance

 

Anti-trypsin antibodies and immunoassay developed by Affigenix enables drug companies to monitor the clearance of the trypsin used in downstream processing of Biologics and Biosimilar.

 

For further information please contact

 

Biotechnology Industry Research Assistance Council (BIRAC)

1 st Floor, MTNL Building, 9, CGO Complex,

Lodhi Road, New Delhi- 110003

Phone: + 91-11-24389600

Email- birac.dbt@nic.in