My Coop Experience

Week 1: New Hire Orientation and Training: During my first week, I participated in several training and conferences. The topics of the orientation and training included: an overview of the Humira manufacturing process, safety and environmental, biotechnology and microbiology overview, documentation training, quality control and data integrity training and gowning certification amount others.

Week 2 and Week 3: Computerized Training and Protocols: My second and third week of my coop experience I spent most of the time reading online training and standardized operation procedures known as SOP’s. In addition, I completed different training in ethics and company polices. During these two weeks I familiarized myself with industry concepts and terms in order to know more about the company and the products that are manufacturing in Abbvie Biotechnology at Barceloneta, Puerto Rico.

Week 4: Manufacturing Sample Processing and Scale-Bioreactor Daily Sampling Training: In this fourth week I started my training in the Technical Operations Upstream laboratory. During this week, I learned how to process the commercial manufacturing samples from Humira campaign and how to perform the daily sampling process of the experiments in small scale-bioreactors.

Week 5 Week 6: Protein A Purification and Media Preparation Training: After a month of my Coop experience, I learned how to perform the protein A purification technique to purify the main protein in the product of Humira. In addition, I participated in these two weeks organizing the small scale bioreactor project of the month and also performed media preparation for the same project.

Week 6: Bioreactor Assembly and Media Transfer: After the organization of the project, I worked with the preparation of the bioreactors. This preparation includes the cleaning of the vessels, the assembly of the tubing needed for the bioreactors, the calibration process for both probes of pH and Dissolved Oxygen (DO), the assembly of all tubes probes into the vessels, and finally the autoclave of each bioreactor. After the autoclave, the media transfers and the setting of the parameters is performed.

Week 7 and Week 8: Operation Shutdown because of Hurricane Maria: During these two weeks the operation in the plant were interrupted because of the imminent pass of Hurricane Maria.

Week 9: Organization of the Lab and Schedule of new projects: Because of Hurricane Maria, we lost two weeks of work. This week, I helped in the cleaning and organization of the laboratory. Basically, during this first week after Hurricane Maria the Upstream team and I dedicated our time in the reschedules of the pending projects and experiments.

Week 10: Cell Growth and Pending Training: In the week 10, I had the opportunity to work in the process of cell growth and cell adaptation. In this process, a cell vials is open and the scale up process is started to obtain higher density of cells for the experiments. In addition, during this week, I completed pending training.

Week 11: Cell Adaptation and Media Preparation: In this week I continued with the cell adaptation and scale up process. Also, I participated in the media preparation for the October project and I had the experience to collaborate in the verification and edition of an important memo related with previous results obtained in the laboratory projects.

Week 12: Bioreactor Assembly, Media Transfer and Cell Inoculation: This preparation includes the cleaning of the vessels, the assembly of the tubing needed for the bioreactors, the calibration process for both probes of pH and Dissolved Oxygen (DO), the assembly of all tubes probes into the vessels, and finally the autoclave of each bioreactor. After the autoclave, the media transfers and the setting of the parameters is performed. Then, the cell inoculation is completed and the experiment is started.

Week 13: Project Daily Sampling and Data Verification: During this week, I worked with the daily sampling of the project. This daily sampling includes the measurements of pH, CO2, DO, cell density, cell viability, and cell diameter, concentration of glucose, lactate, Igg and salts. In addition, I worked with data verification of previous experiments and projects in order to maintain the laboratory notebook updated and well documented.

Week 14: Continue with Project Daily Sampling: In this week I continued with the daily sampling of the project and with the manufacturing sample processing. Also, I received training for the Gravitrap method for protein purification.

Week 15: Special project task: During the week 12 I had the assignment of analyzing a data obtained from the Vi-cell instrument (this instrument is used to measure cell density and viability). My responsibility in this special project was to analyze different settings and parameters of the equipment and compare the results for each of the settings. The main focus of this task was to understand the differences between each setting that are used in the lab and manufacturing area.

Week 16: Bioreactor Assembly and Media Preparation: I worked with the preparation of the bioreactors for another project. This preparation includes the cleaning of the vessels, the assembly of the tubing needed for the bioreactors, the calibration process for both probes of pH and Dissolved Oxygen (DO), the assembly of all tubes probes into the vessels, and finally the autoclave of each bioreactor. After the autoclave, the media transfers and the setting of the parameters is performed.

Week 17: Media Transfer and Cell Inoculation: In this week, I worked with the media transfer and with the cell inoculation process of another project. After the inoculation process, the project initiated and also the project daily sampling procedure.

Week 18: Continuing with the Project Daily Sampling: In this week I continued with the daily sampling of the project and with the manufacturing sample processing.

Week 19: Christmas Vacations

Week 20: Last week of my Coop Experience: During my last week of this Coop experience, I helped in the preparation and organization of another experiment. I worked with the cleaning and assembly of the vessels.