Entry Level: BioTech
Sample a Bioreactor
Simulation vetted by professionals from CMDOs in Greater St Louis and Texas
Simulation Objective:
Determine if the glucose reading is in range
Associated Simulation Library:
Background
Growing cells is a slow and resource-intensive process. That is why it’s important to monitor the growth and health of the cells throughout the process. Monitoring is done by the operator or technician on the manufacturing team. Samples are taken periodically to observe the cell count, glucose level, and signs of contamination. The cell count is used to approximate the rate at which the cells are growing. The glucose level is used to determine if more media is needed. The sample is checked for signs of contamination. Once the final cell count is reached, the cells will be harvested and stored until needed.
The Process
Take a clean 10mL syringe and attach to the sampling port on the bioreactor; 5L or single use 10L bag.
Pull set volume, 3-5mL measure as you pull the volume (for assays: cell count, pH, gasses in the culture, nutrients)
Ensure sample port is closed
Ensure the bioreactor is operating as is (agitator is going; pH has plummeted; no changes in pumps that got bumped; didn’t turn something on/off accidently)
Go to analysis equipment
Gas sample - bc Off gassing, environment gets into sample would distort the sample
Nutrients
Use a cell counter over 10M cells/mL
Dilutions, calculate in PBS or buffer; do NOT use water or cells will burst!
Record results and compare to previous days (critical thinking)
Glucose values and decide to feed more media. Calculate to get within range, how much to add
Or pH get into range by adding acid or bases.
Check for contamination
Visually inspect via microscopy for bacteria
Visually cloudy media is contaminated. Make sure media is clear
Odor - inspect by smell
Resources:
Resources
What must a batch record include? (presentioneze article)
Cell culture video (Thermo Fisher Scientific on YouTube)
Cell culture protocol (Thermo Fisher Scientific)
What is GMP, introduction (FDA article)
Why is GMP important (podcast)
The Exercise
Your role as a lab technician on the bioprocessing team is to maintain theon the bioprocessing team is to assist the operator in monitoring the progress of the cells in the bioreactor.
For this exercise, you will be monitoring the bioreactor progress. You’ll be provided the range at which the cells can be removed from the bioreactor and a table with the hypothetical time course of cell density values. Determine when the cell density is within range.
Task 1 - Track Cell Count
Review Appendix A of the batch record. Using the 3 day time course of cell count measurements, track the growth of the cells in the batch record by writing the cell density counts in the column labeled “Total Cell Counts”. Then determine which step when the cells are ready to be removed by writing “Cells are removed” in the “Additional Comments” column of the Appendix A.
Task 2 - Track Glucose Levels
Review Appendix B of the batch record. Using the 3 day time course of glucose level measurements, track the glucose levels in the column labeled “Glucose Level (g/L)” in the batch record by noting in the column labeled “In range” whether the glucose level is in range by circling either Y, if it is in range, or N, if it is not in range. For the time points when the glucose level is not in range, determine how much glucose to add following step 5.1.8 in the batch record and write the amount in the column labeled “Glucose (200 g/L) added (mL)” in Appendix B.
Deliverables
Task 1 -2
For this job sim, you will complete a batch record noting when the cells can be removed from the bioreactor (Task 1) and the activity around maintaining the glucose level in the bioreactor. (Task 2) The batch record will be reviewed by the operator and supervisor. Once the cells have reached the target concentration that is noted in the batch record, the cells will be harvested and stored until needed.
Additional Tasks
A professional in the field of biomanufacturing may also perform these tasks:
Media formulations and preparation
Harvesting cells
Packaging Technicians
Microscopy
Operating bioreactors
Quality assurance and Quality control
Skills Used to Perform this Task
Documentation and Data recording
Basic math calculation
Adhering to guidelines
Critical thinking
Skills Used in the Field
Clear communication Skills
Aseptic technique
Attention to detail
Image analysis
Data analysis
Continuous improvement
Problem-Solving Skills
Time Management
Teamwork and Collaboration
Adaptability and Flexibility
Integrity
Career Progression
Laboratory Technician > Cell Culture Technician > Research Associate > Cell Culture Specialist > Senior Research Associate > Senior Cell Culture Specialist > Scientist > Senior Scientist
Sample Job Postings
Typical Pay Range $17-20/hr
Thermo Fisher Scientific
Cell Culture Technician | Pay rate: $35-45K
Formulation Technician | Pay rate: $40-50K
Endeavor Consulting Group
Formulation Technician | Pay rate: contract
Washington University in St. Louis
Research Laboratory Technician II | Pay rate: $16.59-24/hr
Sample Job Posting: Formulation Technician
Our client, a global pharmaceutical corporation, has an immediate need for an energetic Formulation Technician to join the team. In this role, you will be responsible for supporting the formulation and preparation of buffers and media used in the production and development of pharmaceutical products. The ideal candidate should have a strong background in pharmacy and extensive hands-on experience with buffer and media formulations.
This is a day shift role in which you would work 12 hour shifts 3-4 days/week in the client's pharma manufacturing facility in St. Louis, Missouri.
Responsibilities
• Prepare and formulate buffers and media for use in manufacturing processes.
• Develop and optimize processes for buffer and media preparation.
• Troubleshoot issues related to buffer and media formulations.
• Maintain a clean and safe work environment.
• Perform routine and non-routine analytical tests on buffers and media.
• Document all activities according to Good Laboratory Practices (GLP) and Standard Operation Procedures (SOP).
• Collaborate with other team members to ensure timely delivery of materials and products.
• Maintain raw material stock levels, supplies, and equipment
Requirements
• Highschool degree or GED is required
• Bachelor’s degree in a scientific discipline is preferred
• 1+ years of experience in a laboratory or GMP manufacturing
• Buffer and media formulations experience in a pharmaceutical setting preferred
• cGMP manufacturing experience preferred
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to accuracy and high-quality work.
• Ability to multitask and manage competing priorities.