R43GM145098

Novel Biomaterial for Enantiomer Separation - Project Summary

The development of methods for the separation, analysis, and resolution of chiral drugs is of important interest for pharmaceutical development. Two enantiomers of the same compound may have the same physical or chemical properties, but show marked differences in how they interact in a human system (i.e., regarding their pharmacology, toxicology, pharmacokinetics, and metabolism).

Thus, the chiral separation of drugs is important to eliminate the unwanted enantiomer from the preparation. Separation of enantiomers is typically achieved by high-performance liquid chromatography (HPLC) where a chiral selector is used in a chiral stationary phase (CSP). CSPs can be composed of several types of molecules, including polysaccharides (i.e., amylose and cellulose) and proteins (e.g., albumin, enzymes), among others.

Only a handful of proteins have been investigated for use as HPLC CSPs despite their unique enantioselective properties. Unfortunately, current protein-based CSPs have low loading capacity, are expensive to prepare, and have limited stability. There is clearly a market need for enzyme and protein-based CSP separation methods with higher loading capacity, less degradation, and extended shelf life.

Based on market research interviews that we have conducted through NSF's I-Corps program on our platform biomaterial technology, it was made clear that the technology for chiral columns has not changed and that innovation in the field was desired. Bondwell Technologies aims to develop a novel high-capacity protein-based selector for use as a CSP based on our innovative biomaterial. The unique qualities of our biomaterial address all of the current limitations of chiral CBHS.

During this proposed Phase I feasibility effort, we will first express the chiral selector enzyme cellobiohydrolase (CBH I) and form our biomaterials. We will test the enzyme in the biomaterial for function to ensure correct folding. We will then prepare our material to be used as a CSP. Finally, we will test for the ability of our biomaterial to separate enantiomers of the beta-blocking drugs, propranolol and alprenolol.

Bondwell Technologies Lp

THE NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS) SUPPORTS BASIC RESEARCH THAT INCREASES OUR UNDERSTANDING OF BIOLOGICAL PROCESSES AND LAYS THE FOUNDATION FOR ADVANCES IN DISEASE DIAGNOSIS, TREATMENT, AND PREVENTION. NIGMS ALSO SUPPORTS RESEARCH IN SPECIFIC CLINICAL AREAS THAT AFFECT MULTIPLE ORGAN SYSTEMS: ANESTHESIOLOGY AND PERI-OPERATIVE PAIN, CLINICAL PHARMACOLOGY ?COMMON TO MULTIPLE DRUGS AND TREATMENTS, AND INJURY, CRITICAL ILLNESS, SEPSIS, AND WOUND HEALING.? NIGMS-FUNDED SCIENTISTS INVESTIGATE HOW LIVING SYSTEMS WORK AT A RANGE OF LEVELSFROM MOLECULES AND CELLS TO TISSUES AND ORGANSIN RESEARCH ORGANISMS, HUMANS, AND POPULATIONS. ADDITIONALLY, TO ENSURE THE VITALITY AND CONTINUED PRODUCTIVITY OF THE RESEARCH ENTERPRISE, NIGMS PROVIDES LEADERSHIP IN SUPPORTING THE TRAINING OF THE NEXT GENERATION OF SCIENTISTS, ENHANCING THE DIVERSITY OF THE SCIENTIFIC WORKFORCE, AND DEVELOPING RESEARCH CAPACITY THROUGHOUT THE COUNTRY.

93.859 - Biomedical Research and Research Training

National Institute of General Medical Sciences (NIGMS) [HHS - NIH]

College Station, Texas 778459660 United States

Single Zip Code

PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-20-260)

Amendment Since initial award the End Date has been extended from 05/03/23 to 05/03/24 and the total obligations have decreased from $275,766 to $275,647.