7:00 a.m.: I arrive at the office and check e-mails for items needing immediate responses for project teams I am part of.
7:30 a.m.: Check production schedule and meeting schedule to plan activities for the day. This is really an exercise to plan your day. If there are important meetings and I am scheduled to work on a process, it is important to plan this with the people you are scheduled with or coordinate someone to cover your production activities to free you up for the meeting. Also, there may be shifts involved on the production schedule that require a shift change or hand-off to a second team of people. The timing of the change and communication of the status is coordinated.
8:00 a.m.: Go down to the production floor to execute work per batch record. I work with two to three other workers, depending on the workload. Usually someone is preparing the equipment to be used, flushing from storage solution, standardizing monitoring equipment, and connecting buffers and solutions to be used. Someone else is preparing the product pool for processing by warming up, mixing, conditioning with buffer (if necessary), and sampling for product quality and retention in case of troubleshooting problems. A third person would either help with sampling or equipment prep.
9:00 a.m. to 12:00 p.m.: While monitoring the production process, I answer e-mail or deal with project issues. We provide status updates on the current process back to the molecule team and the scientist who is responsible and developed the process. Other project issues consist of planning the next run by incorporating process changes (trying different buffers, flow rates, volumes) or reviewing or compiling data for the team.
12:00 p.m.: Break for lunch; usually a team of two to three people process the production for the day unless it is greater than a standard shift (8 hours), then two teams will split the tasks
1:00 p.m.: I return to the production floor to finish processing activities such as liquid chromatography, tangential flow filtration, and viral filtration.
Liquid chromatography consists of a separation of mAbs from contaminants using a column packed with a specific resin to separate based on affinity, size, and ionic strength. This involves column packing as well.
Tangential flow filtration systems are used to concentrate a solution and exchange (diafilter) a solution into another solution for the next step or for final formulation of the product. This is usually done after chromatography when the product is at a high purity level and ready to be formulated for final filling as a bulk solution.
Since we are using mammalian cells to culture our protein (mAbs) the FDA requires steps to mitigate for potential viral contamination. This is done by bulk viral filtering of the product pool through a validated filter system to remove different virus particles.
2:30 p.m.: Clean up and store equipment, sample process pool and store
3:00 p.m.: Stage tomorrow’s process activities and ensure solutions and equipment are ready for use. Occasionally participate on teams that look into new processing technologies, new equipment, automation upgrades, deviation investigations, and training new people.
3:30 p.m.: Review e-mail for additional items needing attention.
4:00 p.m.: Head home.