What we bring

  • Recombinant proteins developed for an array of dreaded infectious diseases encompassing prophylactics and therapeutics.
  • The platform technology can be used for the development of number of products.
  • Does not require highly contained manufacturing infrastructure (BSL-3 and beyond).
  • Campaign-based production possible for each of the platform technology enabling capacity utilization and economies of scale.
  • All products developed in compliance with ICH Q series and specific CTD modules.
  • Each of the candidate developed would have an FTO or novelty with appropriate IP.
  • BioGrit Technologies has expertise across different domains as shown below in Figure 10.
Functions Description
Research & Development
  • Comprehensive In silico analysis of target protein
  • Selection and use of cloning vectors and expression system
  • Upstream and Downstream processes 
  • Physicochemical protein characterization
  • Analytical method development
  • Stability studies
  • Designing, conducting, and interpretation of data from in vitro and proof-of-concept studies
Preclinical studies
  • Design and conduct of preclinical trials in compliance of GLP guidelines  
Clinical Trials
  • Design of clinical trial protocol
  • Preparation of clinical trial documents viz. Investigators Brochure (IB), Case Report Forms (CRF), and Informed Consent Forms (ICF) in compliance with ICH-GCP guidelines
Strategic Regulatory Affairs
  • ICH guideline Q11 – Development and Manufacture of Drug Substances (biotechnological/biological entities)
Global Business Development and Strategy
  • Technology developed by Techinvention Lifecare Pvt. Ltd. for which BioGrit Technologies Inc has exclusive licence and rights for North America
Intellectual Property &

Legal compliance

  • Strong patent portfolio with around 15 patent applications for various product, compositions, and processes
  • Patent drafting and filing through conventional and PCT routes
  • IP evaluation and patent landscaping for interested projects and markets
  • Patentability Analysis, Freedom to Operate Analysis, and Patent Infringement Analysis
Medical Affairs
  • Literature review
  • Target product profiling
  • Conceptualizing, developing and reviewing scientific collaterals viz. abstracts, posters, scientific manuscripts, concept notes, etc