Molecular Standards for AUC Validation and GMP Practices

The discovery of CRISPR-based gene therapy methods using viral vectors, and SARS-CoV-2 vaccines based on lipid nanoparticle formulations has revolutionized the field of personalized medicine, and promises revolutionary applications for curing cancer, genetic disorders, and other diseases on the molecular level. To facilitate the
validation of new therapies, biopharma companies use analytical ultra-centrifugation (AUC) to measure physical properties of the molecules/mixtures in solution. This process is difficult as no validated standards exist for comparison to experimental data and ensuring machines are operating as desired. In this project molecular
standards will be developed by the intern(s) and characterized by AUC to solve this problem. These interns will receive extensive training on state-of-the-art equipment and processes and a highly desirable skillset for future employers. In turn the developed standards will allow AUC Solutions Canada to facilitate further implementation
of AUC in standardized and controlled drug production and validation pipelines generating IP and increasing the client base.

Faculty Supervisor:

Trushar Patel

Student:

Partner:

AUC Solutions

Discipline:

Life Sciences

Sector:

Pharmaceuticals; Biotechnology; Biomanufacturing

University:

University of Lethbridge

Program:

Accelerate

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