Biomanufacturing

Small-molecule drug development has dominated the pharmaceutical industry for decades. Their pharmacokinetic properties are easy to optimize, they are easy to manufacture, and they have a proven track record of success.

However, most small molecules lack specificity, which contributes to a much higher failure rate at the clinical trial stage of development. Their lack of specificity contributes to undesirable side effects and toxicity.

One alternative solution looks at the use of biologics—proteins, monoclonal antibodies, peptides, and gene and cell therapy products—that offer a more specific effect against targets of interest. The demand for expertise in the area of production, recovery, and purification of biologics is met at BRITE by training students to be job-ready for biomanufacturing jobs upon graduation. 

Researchers at BRITE focus on the production of protein-based drugs, which are more complex in structure than small molecules, making them difficult to fully characterize. We look at the production of human proteins in living cells to be used as therapeutic protein drugs. Both upstream and downstream processes are addressed. 

Students enrolled in the PHRM 4110 undergraduate-level course are expected to gain skills in the field of biomanufacturing that will allow them to work as scientists in the biopharmaceutical development and production fields.  Learning objectives include understanding the following: 

• The principles of how to grow and monitor bacterial and mammalian cells on a laboratory scale and the processes to move to large-scale production used in industry
• The concepts of cleaning, sterilization, aseptic inoculation, operation, and monitoring of fermenters and bioreactors, as well as the design and types of fermenters and bioreactors
• The processes for the recovery and purification of proteins produced by cell cultures
• The processes of centrifugation, filtration, and chromatography techniques
• Good manufacturing practices (GMP) and standard operating procedures (SOPs)