Automated Biomanufacturing

Task 1 – Biomanufacturing overview: students will complete an overview of the biomanufacturing industry (resources provided). This task is completed by scoring 80% or higher on the checkpoint.

1.     Review biomanufacturing overview material

a. Introduction to biomanufacturing (https://www.youtube.com/watch?v=xW0sgW7J7sM) video by David Blum formerly of the UGA bioexpression and fermentation facility (https://bff.uga.edu/). The video is 41 minutes long and is rigorous.

b. Bioreactors and their use (Bioprocessing Part 1: Fermentation: https://youtu.be/5eKdZ0dVCCo?feature=shared) and (Bioprocessing Part 2: Separation / Recovery: https://youtu.be/VKpthcW1llU?feature=shared). These videos are 15 and 11 minutes respectively. They explain the principles of upstream and downstream bioprocessing.

2.     Complete and submit the checkpoint individually (questions below)

a. Describe the biomanufacturing industry.

b. What is tangential flow filtration (TFF)?

c. What is homogenization?

d. What is chromatography?

e. What is spray drying?

f.  List 5 products produced through biomanufacturing.

g. What is meant by fermentation?

h. What is the difference between upstream processing and downstream processing?

i.   What is the difference between aerobic and anerobic cells?

j.   What is a batch record?

k. What is recovery?

l.   What is centrifugation?

Task 2 – Employer introduction: students will schedule a meeting with the employer to introduce themselves and become familiar with the business. Meetings can be virtual or in-person, whichever the employer prefers. Care should be taken to record minutes from this meeting using the template provided. Submission/uploading of completed minutes will be required. Students will receive coaching for this task from their project coordinator.

Minutes Template:

Date

Employer name

Team members present

Employer contact name

Employer business and products

Employer jobs

Career paths to jobs

Task 3 – Problem analysis: students will review the problem scenarios, select one on which to focus, and complete an in-depth study (resources provided). An analysis template is provided which students utilize to submit. Employers will respond and provide comments.

Problem statement #1: The conditions in bioreactors must be controlled and this relies on monitoring devices to maintain conditions within a specific range. For example, pH is often controlled to maximize growth and development in the bioreactor. If the pH gets outside of the set range, growth will be inhibited, and the product will not be produced as expected. This problem has several parameters which might impact the pH in the bioreactor. Review the videos below to learn more about how pH influences bioprocessing. How can managing pH become less of a limiting factor in fermentation?

The Impact of pH on Cell Culture in Bioreactors

https://youtu.be/4gRK188sCKo?feature=shared

Sensors in bioreactors

https://www.youtube.com/watch?v=T3DEimHvkAo

Problem statement #2: Like problem #1, dissolved oxygen (DO) is another critical condition which must be managed in bioreactors. Review the video below to learn more about how DO is measured in bioprocessing. How can managing DO become less of a limiting factor in fermentation?

Understanding Dissolved Oxygen (DO) Measurements in Bioprocess

https://www.youtube.com/watch?v=CCfXRnuTELU

Problem statement #3: Cell culture can be automated using various networked control systems. Numerous control systems are commercially available which rely on an array of networked devices. One of the challenges within these bioprocess control systems is interactivity between nodes and/or devices. Review the videos below to learn more about bioprocess control systems. Automation offers integration of various devices and set points. However, most automated systems are limited to managing parameters individually without integration. How might parameter integration improve cell culture management?

Control systems in fermenter

https://youtu.be/ndoXG0NfiYc?feature=shared

Control & Automation Fundamentals : An overview of Process Automation

https://www.youtube.com/watch?v=cM0Bhrjwqxg

Select one of the 3 problems to analyze. Write and submit a problem analysis on the following template.

Problem analysis

Problem statement:

Opportunities for solutions

Limitations to solutions

Task 5 – Solution proposal: students are challenged with developing a novel solution to the problem. Solutions will be captured on a presentation template and delivered to the employer as a group presentation. Students will schedule their presentation with the employer either face-to-face or virtual. Employers and students may invite guests. Employers will complete an evaluation.

Presentations should be limited to 30 minutes with a minimum of 3 team members speaking. PowerPoint presentations are required with EPIC, Riipen, and Georgia Life Sciences recognized. The PowerPoint slides must be submitted a minimum of 24 hours in advance of the presentation.

The solutions must specifically address the problem but are not limited in scope. Please make an effort to propose solutions which are meaningful and could be implemented by the employer. The presentation must include a slide summarizing what the team learned through the experience.