Perspective On: A Cell Culture Lab

Documentation, Documentation, Documentation: Keeping a Record of Everything is Critical to this Small but Mighty Lab

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Though small, the cell culture lab at global product supplier Akron Biotech in Boca Raton, Florida plays a critical role in the company as a whole.  The company specializes in the manufacture and supply of cell biology and cell culture products, providing raw materials to the stem cell and biotools industries, so it relies on cell culture to ensure those products are the best quality they can be.

“Our target market needs stem cells, needs cell culture,” explains Claudia Zylberberg, PhD, CEO/CSO of Akron Biotech. “So every product that needs to have some quality, [it] is the objective to have them fully developed, fully tested and be able to be fully compatible with any specific cell line for specific projects. Those projects require a lot of cell culture and qualification of those products for specific cell lines. That’s what we do.”

The lab has three employees who work on about four to five projects per month and those workers need to have at least a year of experience with handling a tissue culture and two years of experience in lab technology, Akron’s lab supervisor, Andrea Pena, adds.

Aseptic technique and documentation practices are also key skills staff at Akron need in order to work in the cell culture lab.

With cell culture Ms. Pena explains, lab workers are seeing which different aspects and different variables can change the product in making it better or making it worse, which is why documenting everything is so important.

“Everything is pretty much a trial and error [process], so everything has to be documented each day,” she says. “It’s very detail-oriented type of work.”

Staff education must also be updated on a regular basis.

“As far as specific techniques—for example aseptic technique—that needs to be retouched every year,” she says. “The aseptic technique basically just details that everything that they touch is for the production of the product itself so it eliminates all possibility of contamination.”

Anyone interested in working in a cell culture lab like Akron’s should also make sure they have a solid grounding in biology, “So they understand the fundamental aspects of cell culture, like specific phases of the cell and how they grow, ways they can be agitated to express different types of proteins,” Ms.Pena says. “Basically a good education in biochemistry and biotechnology, specifically cell culture.”

Managing the cell culture lab

Managing the cell culture lab

As lab supervisor, Ms. Pena is responsible for making sure the cell culture facility’s equipment is up-to-date and properly calibrated, as well as making sure the employees are comfortable in the cell culture environment.

“I find that if they’re uncomfortable, they get nervous and mistakes can be made,” she says. “So if they’re comfortable and confident then things go a lot smoother.”

Ms. Pena also keeps an eye out to make sure the proper techniques are being used and is also responsible for “making sure that we use the best product for our cell culture, making sure that [staff members] document absolutely everything that they do from the time they start to the time they leave. It’s very essential that all data is collected.”

Making herself available to staff in case they have any questions is also important for Ms. Pena in managing the lab.

“If they have any type of questions about anything technical, [it is important] that they come ask instead of staying quiet and letting things progress,” she says.

In terms of keeping staff motivated Ms. Pena says that while different people are motivated in different ways, it mainly comes down to being supportive, in addition to making sure staff have all the training they need.

“A lot of the staff that we employ need to have the confidence and the reassurance of their superiors, so if they have good feedback and positive feedback from their superiors and they go into the project with a positive mindset, then everything pretty much [builds] from there,” Ms. Pena says. “In order to keep them on point, [you] just have to make sure that if you ask them specific questions, that they’re able to answer you and … that they are involved and in tune with the work they are doing.”

Dr. Zylberberg adds that giving employees a sense of the big picture also helps.

“I think that once they have responsibility for the project, then you give them [an idea] of where that project belongs in the big picture, what the impact that project will have … I think sometimes that is a good motivation for the work,” she says.

Documentation is especially important in keeping the lab organized. Annual equipment maintenance and calibration records are kept on file and similar documentation is needed for employee training and quality control.

On top of that, employees must document everything they do in the lab each day and the data they collected in their own lab binder so that they can go back and review what they did for the whole cell culture procedure they are working on.

“We’ve gone through ISO training, which is extremely stringent as far as documentation practices are concerned,” Ms. Pena adds. “It is essential that every single thing that comes in and goes out, that we touch … has to be documented.”

Things that need to be documented include materials and equipment used, any incidents that occur and any time employees use the fume hood or do any maintenance or cleaning.

“Everything needs the documentation just to ensure that if something does go wrong or something cames back contaminated, we can trace it back to find the actual cause and the culprit and we can address it and fix it at that point,” Ms. Pena explains.

Forgetting to document one thing isn’t always the end of the world, but it’s usually better to be safe than sorry.

“That one thing could be extremely detrimental or the one thing could be overlooked,” she says. “If, for example, the data that they need to input is missing, that could be detrimental in the final results of the project.”

A look inside the Akron cell culture labA look inside the Akron cell culture lab.A day in the life of the lab

The average day in the Akron cell culture lab starts with a lot of paperwork scattered on the table that needs to be gone through before the day’s experiment begins. Once that experiment starts, it involves a lot of walking back and forth between instruments, getting materials and anything else needed for the work.

“You have to keep in mind that within the tissue culture lab, everything is based in one room to not have so much contamination in the area,” Ms. Pena explains. “Basically, you’ll see people in body suits, you’ll see them in shoe covers, hair nets, you’ll see them in full face masks, sleeve covers— a completely aseptically clean area to make sure that the final product isn’t contaminated.”

The day also involves checking on the growth and viability of the cells with microscopes and other equipment as well as cleaning and freezing the cells to supply more samples for the next experiment— aliquoting the cells, drying the
cells, and making sure the cell banks are documented with all the company’s cell lines.

Dr. Zylberberg says cell culture technology has come a long way since the beginning, making that daily work much easier.

“It always was very classic; [it] didn’t have very many pieces of innovation,” she says of how cell culture used to be, adding current advances on the disposable side, scaffolding, and 3D cell culture materials are bringing new products to the cell culture field.

“The applications have expanded a lot,” Ms. Pena adds. “It was very basic and simple and you couldn’t really manipulate it so much before but now there’s so many ways that you can do different types of testing to make sure the cell culture is actually viable. A lot of techniques have changed—they’ve improved over time.”

For Akron specifically, that means tasks such as running a gel take 45 minutes rather than three hours and technology is also much more precise.

“For example in the mycoplasma testing, it’s becoming more and more advanced and able to detect in the very initial stages so you can treat it properly. The technology has advanced quite rapidly in that sense,” Dr. Zylberberg says, adding that tighter quality control regulations and better contamination control have also had a big impact on the cell culture field. “I think there has been a big improvement in the industry and now that we have more cell therapies and cell culture becomes more a part of that, I think more stringent regulation makes the work a little more stressful but we realize we have all the elements in place right now to do better work, even if you compare with the biotech and biopharmaceutical companies,” she explains.

The most interesting project the lab is working on right now involves stem cells.

“It’s been a challenge, but we’ve been trying to build some embryonic stem cells for some work that we’re doing,” Dr. Zylberberg says.

That level of difficulty is due to the sensitivity of the cells, Ms. Pena explains, but it also makes them more interesting than other cells.

“They’re [stem cells] different from other cell cultures because they’re very sensitive and the way that they grow is different,” she says. “It’s cool in the aspect of, visually, you can see them clumping, you can see them split.  Normally it’s difficult with other types of cell lines to see that type of growth. The science is cool from a nerdy, geeky standpoint, but it is cool.”

Main InstrumentsTime tight, but work rewarding

“Time is my biggest challenge,” Ms. Pena says of her biggest obstacle in the lab. “There’s not enough of it—”

“To finish all the things we need to finish,” Dr. Zylberberg chimes in. “I think adding more personnel would be the way to go but a lot of things have to happen at the same time, unfortunately.”

However, that time crunch is also part of what Ms. Pena enjoys most about her work at Akron.

“I like challenge and pressure, the reason being because I feel a sense of accomplishment once I’m given a task that’s very difficult and I have to find thousands of ways to overcome obstacles,” she says.

 Akron Biotech in Boca Raton, FloridaThough it is small, the cell culture lab at global product supplier Akron Biotech in Boca Raton, Florida plays a critical role in the company as a whole.Finally getting the product done and finding out it works the way it is supposed to is another plus of the job, Ms. Pena adds.

“It’s very, very pleasing once we finish, as far as my point in the lab,” she says. “So working from the very bottom all the way to the top, seeing how things progress and get better—I just like the challenge and the fact that I can make a difference, whether it’s a positive or a negative… I feel very accomplished.”

Rachel Muenz, assistant editor for Lab Manager Magazine, can be reached at rachelm@labmanager.com or by phone at 888- 781-0328 x233.

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Toot Your Own Horn

Published: November 2, 2012

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