Biomanufacturing

Minimum Units Required: 60.0 units

The Bachelor of Science in Biomanufacturing program builds upon the Associate in Science in Industrial Biotechnology degree. In the baccalaureate program students gain knowledge in biology, chemistry, engineering, statistics, quality, regulatory affairs, and business. Students use biomanufacturing laboratory facilities to gain process development skills. Many of the courses have been designed with curriculum that aligns with the requirements of certifications from professional organizations. The Bachelor of Science degree is awarded upon successful completion of a total of 120 units that include 60 lower division units and ten upper-division major courses, three upper division general education courses, and electives. All courses in the major must be completed with a minimum grade of C.

Program Learning Outcomes

• Demonstrate the ability to identify and critically analyze two viable options for a biomanufacturing process. The critical analysis will include the technical, financial, and environmental impact of the two options as well as the identification of the benefits and disadvantages of each.

• Produce a professional report and presentation representing their opinion regarding the advantages of selecting a specific biomanufacturing process

• Demonstrate the skills needed to conduct an investigation and analysis of an Out of Specification deviation that occurred during a production step in the manufacturing of a pharmaceutical protein. The student will be able to determine the impact of the OOS deviation on the batch of protein.

• Produce a written Corrective Action Preventative Action report in a format standard to the industry. The report will include evidence to justify their conclusions and action plan.

• Demonstrate the ability to apply Quality by Design (QbD) principles (understanding of the product, the process, and the process control) as adopted by the U.S. Food and Drug Administration (FDA) to design a robust, stable, and controlled manufacturing process for a protein pharmaceutical that can be carried out under current Good Manufacturing Practices (cGMPs). This includes the ability to predetermine values and potential ranges of the critical quality attributes (CQAs) of the product and the critical material attributes (CMAs) of the materials. Students will also be able to determine which parameters would benefit from a Design of Experiments (DoE) approach for their optimization, and construct a strategy for experimental planning and data analysis.

• Use a quality risk assessment approach to perform a criticality assessment to determine the Critical Process Parameters (CPPs) that would need to be monitored and controlled.

Program Requirements