Entry Level: BioTech
Culturing and Passaging CHO Cells
Simulation vetted by professionals from CMDOs in Greater St Louis and Texas
Simulation Objective:
Calculating Final Cell Density
Associated Simulation Library:
Background
A cell culture lab technician at a Contract Development and Manufacturing Organization (CDMO) plays a critical role in the biopharmaceutical production process. Their primary responsibilities revolve around the growing and maintaining cell lines used for producing biologics (e.g., vaccines, monoclonal antibodies, and other therapeutic proteins). Cell culture is important to biotechnology as it provides the cells for study and experimentation. Research scientists will use the cells in their experiments and studies. The cells are maintained in the designated incubator.
-
Thawing, Growing, and Cryopreserving Cells: Handle cell lines from thawing frozen cells, growing them in culture flasks or bioreactors, and cryopreserving them for future use.
Media Preparation: Prepare and sterilize culture media, ensuring it contains the necessary nutrients and growth factors for optimal cell growth.
-
Cell Health Monitoring: Regularly check cell cultures for signs of contamination, abnormal growth, or other issues. This includes daily observation under a microscope and conducting cell counts.
Optimization of Growth Conditions: Adjust parameters such as pH, temperature, oxygen levels, and nutrient concentration to optimize cell growth and productivity.
-
Scaling Up Cultures: Transfer cells from small-scale cultures to larger bioreactors, managing conditions to support large-scale production.
Bioreactor Maintenance: Operate and maintain bioreactors, ensuring they are clean, calibrated, and functioning correctly.
-
Record-Keeping: Maintain accurate and detailed records of all experimental procedures, observations, and results.
Data Analysis: Analyze data from cell cultures to assess growth rates, productivity, and other critical parameters. This often involves using software tools and statistical methods.
-
Adhering to SOPs: Follow standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) to ensure consistency and compliance with regulatory standards.
Contamination Prevention: Implement and adhere to aseptic techniques to prevent contamination of cell cultures.
-
Team Collaboration: Work closely with other technicians, scientists, and engineers to coordinate efforts and share findings.
Reporting: Prepare and present reports on cell culture activities, results, and any issues encountered.
Position Overview
Expectations for a Cell Culture Technician
(expand each entry for full definition)
The Process
Preparation and Set Up - Wear appropriate sterile personal protective equipment (PPE) and sterilize workspace and all equipment and materials entering the workspace
Review protocol - read through the SOP and batch record and attain the materials needed and become knowledgeable with the process
Sample Prep - Prepare a sample of the culture for measurement
Measure Cell Density - Take a reading of the culture and determine the culture’s cell density
Perform Dilution - Calculate the amount of culture and media needed to achieve the final density
Perform record keeping throughout
Ensure bioreactor is operating per specifications
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 the health of the culture. This is a GMP (Good Manufacturing Practices) environment. GMP is a set of manufacturing guidelines applicable to, but not limited to, biotechnology industry manufacturers to ensure consumer quality and safety.
For this exercise, you will be given the culture’s cell density. Use this value to calculate the volume of the culture to transfer and the volume of media to add.
Task 1 - Calculate Cell Density
The cell density of the culture was measured to be 8.7 x 10^6 cells/mL. 1 mL was taken from the 200mL of culture for the measurement. Determine the amount of culture to transfer and media to add if the final cell density should be 0.3 x 10^6 cells/mL in 200mL working volume using the formula:
C1V1 = C2V2
Where C1 is the initial concentration (or known cell density), V1 is the amount to transfer, C2 is the target final cell density, and V2 is the final volume.
NOTE: Fill out section 5.1.6 of this batch record example for this task
Deliverables
Task 1
For this job sim, you will complete the calculation (step 5.1.6) and fill out the batch record to perform the dilution. The batch record will be submitted for review by the supervisor.
Additional Tasks
A professional in the field of biomanufacturing may also perform these tasks:
Media formulations and preparation
Packaging technicians
Microscopy
Operating bioreactors
Quality assurance and Quality control
Skills Used to Perform this Task
Accurate pipetting technique
Documentation and Data recording
Basic math calculation
Adhering to guidelines
Skills Used in the Field
Aseptic technique
Attention to detail
Image analysis
Data analysis
Continuous improvement
Communication Skills
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: Cell Culture Technician
The cell culture group is responsible for the development, scale-up, and transfer of cell culture manufacturing processes for the production of biologics in pre-clinical and clinical stages to enable the development of Client's robust pipeline.
The candidate will be involved with all aspects of laboratory operations to support cell culture process development at bench scale.
Under the supervision of a scientist, the candidate's responsibilities will include:
Bioreactor Support Activities:
Support for 100+ 3 L bioreactor systems
Setup, calibration, troubleshooting and breakdown/decontamination
Track & and perform required maintenance
Perform routine sampling of ongoing cultures
Media Preparation Activities:
Prepare stock solutions and media preps of c media
Filter sterilize and aliquot solutions aseptically
General Lab Support Activities:
Inventory, order, receive, and stock appropriate levels of raw materials and lab consumables
Perform daily lab equipment calibration/verification checks– including pH meters, cell counters and biochemical analyzers
Perform routine lab equipment/glassware cleaning and maintenance activities
Data acquisition in paper and electronic systems
Weekend Support Activities:
Independently execute weekend requests for sampling and feeding of ongoing cultures
Communicate issues to experiment owners and work to resolve issues
Experience:
Years of experience/education and/or certifications required:
Bachelor's or Associate's degree in Biology, Biotechnology, or related field + Experience in a laboratory 0-3 years