Implementation and Evaluation of Experiential Learning to Reinforce Research & Development Skills in a Biopharmaceutical Process Development Course

Deborah Sweet Goldberg

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Conference: 2024 ASEE Annual Conference & Exposition
Location: Portland, Oregon
Publication Date: June 23, 2024
Start Date: June 23, 2024
End Date: July 12, 2024
Conference Session: Biomedical Engineering Division (BED) Technical Session 3
Tagged Division: Biomedical Engineering Division (BED)
Permanent URL: https://peer.asee.org/47573

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Deborah Sweet Goldberg University of Maryland, College Park

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Deborah S. Goldberg is a full-time senior lecturer in the Fischell Department of Bioengineering at the University of Maryland, College Park. She is passionate about teaching and mentoring students to prepare them for diverse careers in bioengineering.

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Abstract

Engineering undergraduate programs must prepare students to enter Research & Development focused post-graduate work, whether in industry or academia. However, traditional engineering coursework may not always adequately cover R&D skills. This work focuses on implementing and evaluating experiential learning activities in a biopharmaceutical process development course. These activities were designed to build students’ R&D skills including designing experiments, developing laboratory protocols, analyzing data, optimizing a process, and making decisions based on data.

Experiential learning was implemented in two ways: Students engaged in “simulated industry experiences” (SIEs) where they were challenged to solve open-ended industry relevant problems in teams in class. In addition, students completed hands-on laboratory exercises with common instrumentation found in the biopharmaceutical industry. Students who were enrolled in the course in Fall 2022 participated in the simulated industry experiences only, while students in Spring 2023 completed the same simulated industry experiences plus a brief hands-on laboratory experience. SIEs were conducted at the end of each content module and included 1) protocol development for protein concentration measurement, 2) development of an efficient bioreactor seed train, 3) scale-up and fit to plant assessment for protein A chromatography and 4) solution preparation for a formulation screening experiment. In each case, students were given multiple criteria to consider when determining their final output, which encouraged them to weigh various factors including efficiency and economics. In the hands-on laboratory exercises, students measured the impact of formulation parameters (pH and ionic strength) on protein-protein interactions and viscosity of a model protein, bovine serum albumin (BSA). Six teams of students analyzed six different solution conditions and then students analyzed the shared data set.

Pre- and post-surveys were used to determine how students’ self-perceived confidence in R&D skills and preparation for R&D based careers changed as a result of the course, and students were also surveyed after each experiential learning activity to understand which skills were reinforced and what they learned from the experience. In both semesters, students made significant gains in their perceived confidence in all five R&D skills, with process optimization and making decisions based on data showing the greatest gains. Students who completed both the SIEs and the hands-on laboratory experiences showed greater gains in their confidence in their ability to analyze data and make decisions based on data compared to students who only completed the SIEs, showing added value of the hands-on experiments. Students were also asked about how prepared they felt to complete hands-on laboratory research and to work in industry as a process development engineer. Again, students who experienced both the SIEs and the hands-on experience showed greater gains, with over 70% of the students indicating they felt strongly prepared, compared to 45% in the case of SIE only. Survey data showed that each simulated industry experience strongly reinforced 2-3 of the 5 identified R&D skills, with all skills being reinforced through the four SIEs in total. Students perceived that the hands-on experiments reinforced the R&D skills the most, with 80-100% of students indicating that they somewhat or strongly agreed the skill was reinforced, across all five skills.

The conference paper and presentation will include additional information about the design of the experiential learning activities so that instructors can implement similar activities in their courses to reinforce R&D skills. Additional data including comparison of student pre- and post-scores on an experimental design assessment and analysis of student qualitative feedback on the experiential learning activities will also be shared.

Citation
Format

Goldberg, D. S. (2024, June), Implementation and Evaluation of Experiential Learning to Reinforce Research & Development Skills in a Biopharmaceutical Process Development Course Paper presented at 2024 ASEE Annual Conference & Exposition, Portland, Oregon. https://peer.asee.org/47573

TY  - CPAPER
AB  - Engineering undergraduate programs must prepare students to enter Research &amp;amp; Development focused post-graduate work, whether in industry or academia. However, traditional engineering coursework may not always adequately cover R&amp;amp;D skills. This work focuses on implementing and evaluating experiential learning activities in a biopharmaceutical process development course. These activities were designed to build students’ R&amp;amp;D skills including designing experiments, developing laboratory protocols, analyzing data, optimizing a process, and making decisions based on data. 

Experiential learning was implemented in two ways: Students engaged in “simulated industry experiences” (SIEs) where they were challenged to solve open-ended industry relevant problems in teams in class. In addition, students completed hands-on laboratory exercises with common instrumentation found in the biopharmaceutical industry. Students who were enrolled in the course in Fall 2022 participated in the simulated industry experiences only, while students in Spring 2023 completed the same simulated industry experiences plus a brief hands-on laboratory experience. SIEs were conducted at the end of each content module and included 1) protocol development for protein concentration measurement, 2) development of an efficient bioreactor seed train, 3) scale-up and fit to plant assessment for protein A chromatography and 4) solution preparation for a formulation screening experiment. In each case, students were given multiple criteria to consider when determining their final output, which encouraged them to weigh various factors including efficiency and economics. In the hands-on laboratory exercises, students measured the impact of formulation parameters (pH and ionic strength) on protein-protein interactions and viscosity of a model protein, bovine serum albumin (BSA). Six teams of students analyzed six different solution conditions and then students analyzed the shared data set. 

Pre- and post-surveys were used to determine how students’ self-perceived confidence in R&amp;amp;D skills and preparation for R&amp;amp;D based careers changed as a result of the course, and students were also surveyed after each experiential learning activity to understand which skills were reinforced and what they learned from the experience. In both semesters, students made significant gains in their perceived confidence in all five R&amp;amp;D skills, with process optimization and making decisions based on data showing the greatest gains. Students who completed both the SIEs and the hands-on laboratory experiences showed greater gains in their confidence in their ability to analyze data and make decisions based on data compared to students who only completed the SIEs, showing added value of the hands-on experiments. Students were also asked about how prepared they felt to complete hands-on laboratory research and to work in industry as a process development engineer. Again, students who experienced both the SIEs and the hands-on experience showed greater gains, with over 70% of the students indicating they felt strongly prepared, compared to 45% in the case of SIE only. Survey data showed that each simulated industry experience strongly reinforced 2-3 of the 5 identified R&amp;amp;D skills, with all skills being reinforced through the four SIEs in total. Students perceived that the hands-on experiments reinforced the R&amp;amp;D skills the most, with 80-100% of students indicating that they somewhat or strongly agreed the skill was reinforced, across all five skills. 

The conference paper and presentation will include additional information about the design of the experiential learning activities so that instructors can implement similar activities in their courses to reinforce R&amp;amp;D skills. Additional data including comparison of student pre- and post-scores on an experimental design assessment and analysis of student qualitative feedback on the experiential learning activities will also be shared. 

AU  - Deborah Sweet Goldberg
CY  - Portland, Oregon
DA  - 2024/06/23
PB  - ASEE Conferences
TI  - Implementation and Evaluation of Experiential Learning to Reinforce Research & Development Skills in a Biopharmaceutical Process Development Course
UR  - https://peer.asee.org/47573
ER  -