Dhruv Sareen

You can’t take it if you don’t make it

/ Kevin McCormack / Leave a comment
Biomedical specialist Mamadou Dialio at work in the Cedars-Sinai Biomanufacturing Center. Photo by Cedars-Sinai.

Following the race to develop a vaccine for COVID-19 has been a crash course in learning how complicated creating a new therapy is. It’s not just the science involved, but the logistics. Coming up with a vaccine that is both safe and effective is difficult enough, but then how do you make enough doses of it to treat hundreds of millions of people around the world?

That’s a familiar problem for stem cell researchers. As they develop their products they are often able to make enough cells in their own labs. But as they move into clinical trials where they are testing those cells in more and more people, they need to find a new way to make more cells. And, of course, they need to plan ahead, hoping the therapy is approved by the Food and Drug Administration, so they will need to be able to manufacture enough doses to meet the increased demand.

We saw proof of that planning ahead this week with the news that Cedars-Sinai Medical Center in Los Angeles has opened up a new Biomanufacturing Center.

Dr. Clive Svendsen, executive director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute, said in a news release, the Center will manufacture the next generation of drugs and regenerative medicine therapies.

“The Cedars-Sinai Biomanufacturing Center leverages our world-class stem-cell expertise, which already serves scores of clients, to provide a much-needed biomanufacturing facility in Southern California. It is revolutionary by virtue of elevating regenerative medicine and its therapeutic possibilities to an entirely new level-repairing the human body.”

This is no ordinary manufacturing plant. The Center features nine “clean rooms” that are kept free from dust and other contaminants. Everyone working there has to wear protective suits and masks to ensure they don’t bring anything into the clean rooms.

The Center will specialize in manufacturing induced pluripotent stem cells, or iPSCs. Dhruv Sareen, PhD, executive director of the Biolmanufacturing Center, says iPSCs are cells that can be turned into any other kind of cell in the body.

“IPSCs are powerful tools for understanding human disease and developing therapies. These cells enable us to truly practice precision medicine by developing drug treatments tailored to the individual patient or groups of patients with similar genetic profiles.”

The Biomanufacturing Center is designed to address a critical bottleneck in bringing cell- and gene-based therapies to the clinic. After all, developing a therapy is great, but it’s only half the job. Making enough of it to help the people who need it is the other half.

CIRM is funding Dr. Svendsen’s work in developing therapies for ALS and other diseases and disorders.  

What to be thankful for this Thanksgiving: scientists hard at work

/ Yimy Villa / Leave a comment
Biomedical technician Louis Pinedo feeds stem cells their special diet. Photo by Cedars-Sinai.

With Thanksgiving and Black Friday approaching in the next couple of days, we wanted to give thanks to all the scientists hard at work during this holiday weekend. Science does not sleep–the groundbreaking research and experiments that are being conducted do not take days off. There are tasks in the laboratory that need to be done daily otherwise months, even years, of important work can be lost in an instant.

Below is a story from Cedars-Sinai Medical Center that talks about one of these scientists, Louis Pinedo, that will be working during this holiday weekend.

Stem Cells Don’t Take the Day Off on Thanksgiving

Inside a Cedars-Sinai Laboratory, Where a Scientist Will be Busy Feeding Stem Cells During the Holiday

While most of us are stuffing ourselves with turkey and pumpkin pie at home on Thanksgiving Day, the staff at one Cedars-Sinai laboratory will be on the job, feeding stem cells.

“Stem cells do not observe national holidays,” says Loren Ornelas-Menendez, the manager of a lab that converts samples of adult skin and blood cells into stem cells—the amazing “factories” our bodies use to make our cells. These special cells help medical scientists learn how diseases develop and how they might be cured.

Stem cells are living creatures that must be hand-fed a special formula each day, monitored for defects and maintained at just the right temperature. And that means the cell lab is staffed every day, 52 weeks a year.

These cells are so needy that Ornelas-Menendez jokes: “Many people have dogs. We have stem cells.”

Millions of living stem cells are stored in the David and Janet Polak Foundation Stem Cell Core Laboratory at the Cedars-Sinai Board of Governors Regenerative Medicine Institute. Derived from hundreds of healthy donors and patients, they represent a catalogue of human ills, including diabetes, breast cancer, Alzheimer’s disease, Parkinson’s disease and Crohn’s disease.

Cedars-Sinai scientists rely on stem cells for many tasks: to make important discoveries about how our brains develop; to grow tiny versions of human tissues for research; and to create experimental treatments for blindness and neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) that they are testing in clinical trials.

The lab’s main collection consists of induced pluripotent stem cells, or iPSCs, which mimic the all-powerful stem cells we all had as embryos. These ingenious cells, which Cedars-Sinai scientists genetically engineer from adult cells, can make any type of cell in the body—each one matching the DNA of the donor. Other types of stem cells in the lab make only one or two kinds of cells, such as brain or intestinal cells.

Handy and versatile as they are, stem cells are high-maintenance. A few types, such as those that make connective tissue cells for wound healing, can be fed as infrequently as every few days. But iPSCs require a daily meal to stay alive, plus daily culling to weed out cells that have started to turn into cells of the gut, brain, breast or other unwanted tissues.

So each day, lab staff suit up and remove trays of stem cells from incubators that are set at a cozy 98.6 degrees. Peering through microscopes, they carefully remove the “bad” cells to ensure the purity of the iPSCs they will provide to researchers at Cedars-Sinai and around the world.

While the cells get sorted, a special feeding formula is defrosting in a dozen bottles spread around a lab bench. The formula incudes sodium, glucose, vitamins and proteins. Using pipettes, employees squeeze the liquid into food wells inside little compartments that contain the iPSCs. Afterward, they return the cells to their incubators.

The lab’s 10 employees are on a rotating schedule that ensures the lab is staffed on weekends and holidays, not just weekdays. On Thanksgiving Day this year, biomedical technician Louis Pinedo expects to make a 100-mile round trip from his home in Oxnard, California, to spend several hours at work, filling nearly 600 feeding wells. On both Christmas and New Year’s Day, two employees are expected to staff the lab.

All this ceaseless effort helps make Cedars-Sinai one of the world’s top providers of iPSCs, renowned for consistency and quality. Among the lab’s many clients are major universities and the global Answer ALS project, which is using the cells in its search for a cure for this devastating disease.

That’s why the lab’s director, Dhruv Sareen, PhD, suggests that before you sit down to your Thanksgiving feast, why not lift a glass to these hard-working lab employees?

“One day the cells they tend could lead to treatments for diseases that have plagued humankind for centuries,” he says. “And that’s something to be truly thankful for.”